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

Catalog Number	2972000000
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	10/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mattress was evaluated and no malfunctions or defects were found.The customer reported that the footboard may have been removed which would have caused the mattress therapy to stop.
Event or Problem Description
It was reported the patient's skin broke down on the mattress.
Additional Manufacturer Narrative
Through discussion with the account, it was found that the patient developed a blister on their sacrum that was treated with petroleum gauze and an over-the-counter foam.This is considered to be an s2 event, and not a serious injury.
Event or Problem Description
It was reported the patient's skin broke down on the mattress.

• Brand Name: ISOLIBRIUM SUPPORT SURFACE - D
• Common Device Name: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 8096614
• Report Number: 0001831750-2018-01442
• Device Sequence Number: 14139677
• Product Code: IKZ
• UDI-Device Identifier: 07613327278453
• UDI-Public: 07613327278453
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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?: No
• Operator of Device: No Information
• Device Catalogue Number: 2972000000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1