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

Model Number 2972

Device Problem Material Too Soft/Flexible (4007)

Patient Problem Pressure Sores (2326)

Event Date 02/17/2021

Event Type  Injury  

Event Description

It was reported that after laying on a deflated mattress overnight, the patient developed a pressure injury.The user facility reported the patient was evaluated and it was determined the injury was consistent with a dti and was treated with advanced cavilon ointment and mepilex foam dressing.

Event Description

It was reported that after after laying on a deflated mattress overnight, the patient developed a pressure injury.The user facility reported the the patient was evaluated and it was determined the injury was consistent with a dti and was treated with advanced cavilon ointment and mepilex foam dressing.

Manufacturer Narrative

After investigation it was determined the injury occurred as a result of user error.H codes updated to reflect investigation results.

• 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: 11466969
• MDR Text Key: 239388259
• Report Number: 0001831750-2021-00661
• 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: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• 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: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability