Device product
Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by qualified medical professionals to adapt a patient helper to a hospital bed. The patient helper is used to aid and assist the patient's mobility within a hospital bed and during bed ingress and egress.
Z-1546-2013
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 64424
- Status
- Terminated
- Classification
- Class II
- Quantity
- 344 Units
- Official record key
device-enforcement:Z-1546-2013
Official wording
Reason: The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube.
Code information: Part number 00-0965-002-01
Distribution pattern: Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CT, FL, HI, IL, KY, MA, MD, MN, MO, NE, NJ, NY, OH, OK, PA, TN, TX, WA, and WI; and country of Canada.
Derived failure modes
-
Unknown
The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube.