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

Model Number 297300000000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 03/01/2023

Event Type  malfunction  

Event Description

It was reported that the customer had a patient experience minor pressure injuries on an isolibrium pe support surface, although not specific serial numbers were provided.A stryker representative checked all of the customer's isolibrium pe units and all were found to be operating correctly, likely indicating that the alleged injuries were the result of use error and not due to any failure of the stryker products.

Manufacturer Narrative

The customer provided the serial number of the unit after the initial mdr was submitted.B5 updated to reflect this.

Event Description

It was reported that the customer had a patient experience minor pressure injuries on an isolibrium pe support surface.A stryker representative checked all of the customer's isolibrium pe units and all were found to be operating correctly, likely indicating that the alleged injuries were the result of use error and not due to any failure of the stryker products.

• Brand Name: ISOLIBRIUM PE SUPPORT SURFACE
• Type of Device: 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: 16636513
• MDR Text Key: 312224412
• Report Number: 0001831750-2023-00321
• Device Sequence Number: 1
• Product Code: IKZ
• UDI-Device Identifier: 07613327523867
• UDI-Public: 07613327523867
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

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?: Yes
• Device Model Number: 297300000000
• Device Catalogue Number: 297300000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 03/01/2023
• Supplement Dates FDA Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other