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

Model Number	2972
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after laying on a deflated mattress overnight, the patient developed a pressure injury.The user facility reported the patient was evaluated and it was determined the injury was consistent with a dti and was treated with advanced cavilon ointment and mepilex foam dressing.
Event or Problem Description
It was reported that after after laying on a deflated mattress overnight, the patient developed a pressure injury.The user facility reported the the patient was evaluated and it was determined the injury was consistent with a dti and was treated with advanced cavilon ointment and mepilex foam dressing.
Additional Manufacturer Narrative
After investigation it was determined the injury occurred as a result of user error.H codes updated to reflect investigation results.

• 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: 11466969
• Report Number: 0001831750-2021-00661
• Device Sequence Number: 3597483
• Product Code: IKZ
• UDI-Device Identifier: 07613327278453
• UDI-Public: 07613327278453
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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?: No
• Operator of Device: No Information
• Device Model Number: 2972
• Device Catalogue Number: 2972000000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 05/19/2021
• 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: Disability