MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOTOUR, 84 INCH,STD, END406; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Catalog Number 2872000012

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

Patient Problems Pain (1994); Pressure Sores (2326)

Event Date 11/09/2023

Event Type  Injury  

Event Description

It was reported that, while using the surface, the patient complained of pain in their sacral area.It was discovered that the surfaces gel had separated, and the patient was sitting on the frame of the mattress.The patient sustained a new stage 2 pressure injury.Attempts are being made to gather additional details from the user facility.

Event Description

It was reported that, while using the surface, the patient complained of pain in their sacral area.It was discovered that the surfaces gel had separated, and the patient was sitting on the frame of the mattress.The patient sustained a new stage 2 pressure injury.

Manufacturer Narrative

This event was previously evaluated through an internal investigation of the failure mode and found to not pose any additional risk to the patient.From this information, a stryker quality assurance engineer determined that the stage 2 pressure injury resulting from uneven pressure distribution was likely not due to any component level malfunction as the gel issue alleged.This issue was resolved for the customer by replacing the surface.

• Brand Name: ISOTOUR, 84 INCH,STD, END406
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• 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: 18183431
• MDR Text Key: 328688660
• Report Number: 0001831750-2023-01345
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 07613327424638
• UDI-Public: 07613327424638
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 2872000012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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