MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOLIBRIUM SUPPORT SURFACE - D; BED, PATIENT ROTATION, POWERED

Model Number	2972
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has not identified a specific unit or made one available for evaluation.
Event or Problem Description
It was reported that the max inflate on the mattress had not inflated it to the degree a nurse had expected.The nurse tried to boost the patient and sustained an unspecified back injury while doing so.No treatment details have been provided.No impact or adverse consequence to the patient has been reported.
Additional Manufacturer Narrative
The section h codes have been updated to more accurately reflect the completed investigation.
Event or Problem Description
It was reported that the max inflate on the mattress had not inflated it to the degree a nurse had expected.The nurse tried to boost the patient and sustained an unspecified back injury while doing so.No treatment details have been provided.No impact or adverse consequence to the patient has been reported.

• Brand Name: ISOLIBRIUM SUPPORT SURFACE - D
• Common Device Name: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 11172632
• Report Number: 0001831750-2021-00018
• Device Sequence Number: 3477505
• Product Code: IKZ
• UDI-Device Identifier: 07613327278453
• UDI-Public: 07613327278453
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 2972
• Device Catalogue Number: 2972000000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other