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 01/24/2023

Event Type  Injury  

Event Description

It was reported that a severely ill high risk with low mobility patient sustained a deep tissue injury.Through communication with the customer, it was reported that the mattress was not deflated.Treatment information was not able to be obtained.

Manufacturer Narrative

There are many factors that contribute to pressure ulcer development including heat, moisture, pressure braden scale ratings, patient mobility, nursing monitoring, and rotation schedules.Based on the information provided there was no defect or malfunction with the surface that would have caused or contributed to the pressure injury.The device was not made accessible for testing.

• 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: melissa millard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 16405385
• MDR Text Key: 309891386
• Report Number: 0001831750-2023-00300
• 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
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 297300000000
• Device Catalogue Number: 297300000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: No
• 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