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

Model Number 2972

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pressure Sores (2326)

Event Date 01/04/2021

Event Type  Injury  

Event Description

It was reported patients are experiencing skin breakdown while using the mattresses.No information has been provided regarding the severity or treatment of the skin breakdown.Attempts have been made to reach the customer for more information; however, the customer has not responded to these attempts.

Manufacturer Narrative

The user facility was not able to provide specific models or serial numbers for a device evaluation.It was initially reported that the severity and treatment of the skin breakdown was unknown; however, the user facility provided more information.Section b5 has been updated to reflect this.H3 other text : user facility was unable to provide a serial number.

Event Description

It was reported patients are experiencing skin breakdown while using the mattresses.Upon follow up, the user facility stated they noticed a general increase in patients experiencing skin breakdown and were unable to tie it to a specific instance.Since there was no specific instance, the user facility was unable to provide information on the severity of the skin breakdown.

• Brand Name: ISOLIBRIUM SUPPORT SURFACE - D
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 11261169
• MDR Text Key: 229813031
• Report Number: 0001831750-2021-00461
• Device Sequence Number: 1
• Product Code: IKZ
• UDI-Device Identifier: 07613327278453
• UDI-Public: 07613327278453
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2972
• Device Catalogue Number: 2972000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other