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

Model Number	2972
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	01/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patients are experiencing skin breakdown while using the mattresses.No information has been provided regarding the severity or treatment of the skin breakdown.Attempts have been made to reach the customer for more information; however, the customer has not responded to these attempts.
Additional Manufacturer Narrative
The user facility was not able to provide specific models or serial numbers for a device evaluation.It was initially reported that the severity and treatment of the skin breakdown was unknown; however, the user facility provided more information.Section b5 has been updated to reflect this.H3 other text : user facility was unable to provide a serial number.
Event or Problem Description
It was reported patients are experiencing skin breakdown while using the mattresses.Upon follow up, the user facility stated they noticed a general increase in patients experiencing skin breakdown and were unable to tie it to a specific instance.Since there was no specific instance, the user facility was unable to provide information on the severity of the skin breakdown.

• 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: 11261169
• Report Number: 0001831750-2021-00461
• Device Sequence Number: 14125382
• Product Code: IKZ
• UDI-Device Identifier: 07613327278453
• UDI-Public: 07613327278453
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 03/31/2021

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: 01/04/2021
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 03/31/2021
• 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