Hill-Rom
Compella Bariatric Bed System Advisory Dec 2021
Advisory
4 Pages
Preview
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ADVISORY NOTICE
FA-2021-12-003-BAT-008
Subject: Compella- Exposed AC Power Conductors Commercial name and details of the affected product: Product Model Compella™ Bariatric Bed System P7800A Compella Therapy Air Supply Unit P7810A
Manufacturing Dates All beds manufactured All Air Supply units manufactured
FA Number: FA-2021-12-003-BAT-008 Type of action: Advisory Notice ----------------------------------------------------------------------------------------------------------------------------------------Date: Description of the problem Over the lifespan of the Compella Bed and Compella Air Supply Unit their respective powers cord can become damaged due to improper storage. Hillrom has become aware of complaints related to exposed AC power conductors due to cut or damaged power cords. Potential risk The resulting damage may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains. Where proper intended use practice is followed, i.e cables are stored correctly during transport of the bed; no such damage will occur to the power cords. Recommendations to mitigate the risk: Please follow the instructions outlined within the user manual for the Compella Bed and Compella Air Supply Unit. Compella Bariatric Bed To help prevent personal injury and/or equipment damage, before you transport the bed, make sure that the power cord, hoses, and other equipment are correctly stowed. There are two blue hooks on the inside of the head-end frame to stow the power cords for transport. Wrap the cords around the hooks so that they do not drag on the floor. (Fig 1.) Fig. 1- Compella Cord Hooks.
- Compella Air Supply Unit Before you transport the bed, remove the air supply unit from the footboard. Failure to do so could cause equipment damage. 1.Turn the air supply unit Off. 2.Unplug the air supply unit from the AC power source.
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ADVISORY NOTICE
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NOTE: The air surface will stay inflated during transport. To help with lateral transfers, Max Inflate the surface before you disconnect it from the AC power; the surface will then stay firm. 3. Unplug the power cord from the air supply unit. 4.Use the magnets on the power cord to keep the power cord attached to the metal frame of the bed and off the floor. (Fig 2) NOTE: Make sure that the magnets do not interfere with the movement of the foot end section when the foot section is lengthened or shortened.
Fig. 2- Power Cord Magnets
5. Disconnect the three color-coded air hoses from the patient left-hand side of the air supply unit. 6. Lift the unit and its hoses over the footboard and set the unit and hoses on the foot or side section of the bed. 7.At the head end of the bed, unplug the power cords for both the bed and the air supply unit. Use the blue cord hooks at the head section to store cords during transport. 8.Put the brake/steer pedals in the Steer or Neutral position as necessary. 9.Transport the patient. If you identify exposed wires on your power cords/transformers, do NOT make physical contact with it. Switch off the plug at the wall and contact your Biomedical/Clinical Engineering department. Actions to be taken by end user: Please follow our recommendations to mitigate the risk and please share with potential users in your organization as a reminder to follow the instructions for proper handling techniques. Please inspect your power cords upon receipt of this notification. If a power cord is damaged, please contact Technical Support to arrange to have it replaced. Complete the attached response form and return to [email protected] within 2 weeks. Actions to be taken by distributors: Please share with your end users, complete the attached response form and return to [email protected] within 2 weeks. Contact [email protected] to receive an electronic copy of this notification and response form for onward distribution. Transmission of this Notice: Please ensure this notice is circulated to all appropriate personnel. This may include, but is not limited to: • A&E departments • Adult intensive care units • All Maternity wards & Clinics • Biomedical engineering staff • Clinical governance leads • Day case theatres • EBME departments
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• In-house maintenance staff • IV nurse specialists • Medical directors • Nursing executive directors • Theatres • Pediatric intensive care units • Risk managers
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ADVISORY NOTICE
• Equipment stores & Libraries • Health and safety managers
FA-2021-12-003-BAT-008
• Supplies managers
Contact reference person: If you have any questions regarding this notice, please contact Hillrom Technical Support. Market Region Country Austria Germany Switzerland
Phone Number (+ 43) 2 243 285 50 (+ 49) 2 0149869500 (+ 41) 8 48 811530
Technical Support Email [email protected] [email protected] [email protected]
Netherlands Belgium Spain Italy France Sweden UK/Ireland Eastern Europe Countries
(+ 31) 347 323 532
[email protected] [email protected] [email protected] [email protected] [email protected] [email protected] [email protected]
Middle East & Africa India Sub Continent
(+ 34) 9 36856000 (+ 39) 02 950541 (+ 33) 0 820 012345 (+ 46) 20-781030 (+ 44) 1530 562176 Contact your Local Hillrom Distributor Contact your Local Hillrom Distributor Contact your Local Hillrom Distributor
Hillrom considers patient safety and customer satisfaction our top priorities. We appreciate your time and attention in reading this important notification. Yours sincerely,
Director Quality
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ADVISORY NOTICE
FA-2021-12-003-BAT-008
Response Form Subject: Compella- Exposed AC Power Conductors (FA-2021-12-003-BAT-008) It is important that you return this form/receipt as acknowledgement of your receipt and provide us with the necessary information. Please complete the following with the correct information and return this Response Form within 2 weeks.
Hillrom account number (if known): ____________________________________ ____________ Name of the facility: _____________________________________________________________ Address of the facility: ______________________________________________ _____________ City: ______________________Zip:_________________ Country:________________________ Facility Contact Person Name: (print) ______________________________________________________________________________ Signature: Date: _____/______/_____ Title:__________________________________ Phone: _________________________________ Email: __________________________________________________________________________ Check actions taken: We have reviewed and understand the attached Advisory Notice ☐Yes ☐No Results from the inspection of our product inventory show we have: ☐ We do not have the affected products. ☐ We have affected products. Quantity _____________ For Distributors Only: I confirm I have shared this notice with our end users: ☐Yes ☐No Comments
Response form shall be returned to [email protected] within 2 Weeks.
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