MAUDE Adverse Event Report: STRYKER MEDICAL STYKER SOFCARE DUOGAURD OVERLAY; BED, FLOTATION THERAPY, POWERED

Catalog Number DG212

Device Problem Deflation Problem (1149)

Patient Problem No Information (3190)

Event Date 12/17/2014

Event Type  No Answer Provided  

Event Description

Stryker duoguard overlays are utilized when our patients are assessed as being a high risk for skin breakdown.It has been reported that multiple overlays have been found deflated when utilized.Education was provided to nursing to ensure correct utilization, however the problem continues.

• Brand Name: STYKER SOFCARE DUOGAURD OVERLAY
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): STRYKER MEDICAL; 3800 e centre avenue; portage MI 49002
• MDR Report Key: 4510180
• MDR Text Key: 21769826
• Report Number: 4510180
• Device Sequence Number: 3
• Product Code: IOQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/07/2015
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Device Catalogue Number: DG212
• Device Lot Number: K3-CF-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1