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

Model Number	2972
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient sustained a type 2 pressure injury.
Event or Problem Description
It was reported that the patient sustained a type 2 pressure injury.
Additional Manufacturer Narrative
The surface was evaluated by a stryker field service technician, who found that the hospital acquired pressure injury was not due to any component level defect or malfunction of the surface.Additionally, a stryker quality assurance engineer spoke with the sales account manager who explained that the mattress had lost power from the bed.The nurse attending to the patient was new and did not check the foot end of the bed to ensure the mattress was powered and detected by the bed.It is unknown how long the surface was without power.The patient received a stage 2 pressure injury.The issue was resolved for the customer by the sales rep conducting additional training with the nurse and confirming no further action is needed by stryker at this time.

• 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: marleca lane ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 16531252
• Report Number: 0001831750-2023-00311
• Device Sequence Number: 6126733
• Product Code: IKZ
• UDI-Device Identifier: 07613327278453
• UDI-Public: 07613327278453
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/06/2023

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
• Device Model Number: 2972
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• 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