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

Catalog Number	2972000000
Medical Device Problem Codes	Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the unit "was not inflating and deflating properly" and that this caused an unspecified pressure injury.
Event or Problem Description
It was reported that the unit "was not inflating and deflating properly" and that this caused an unspecified pressure injury.Further investigation identified that the surface was not likely to have caused or contributed to the alleged injury as an inspection by stryker field service found no defect with the unit.
Additional Manufacturer Narrative
The b5 summary and section h codes have been updated to reflect the completed investigation.

• 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
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 19119853
• Report Number: 0001831750-2024-00367
• Device Sequence Number: 18220654
• Product Code: IKZ
• UDI-Device Identifier: 07613327278453
• UDI-Public: 07613327278453
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/03/2024

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
• Device Catalogue Number: 2972000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown