MAUDE Adverse Event Report: STRYKER MEDICAL STRYKER ISOFLEX MATTRESS; MATTRESS, FLOTATION THERAPY, NON-POWERED

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 01/22/2015

Event Type  malfunction  

Event Description

Per the isoflex brochure, the dartex/nylon cover is fluid impermeable.Mattress cover was unzipped to find a blood stain within the mattress.

• Brand Name: STRYKER ISOFLEX MATTRESS
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): STRYKER MEDICAL; 3800 east centre avenue; portage MI 49002 582
• MDR Report Key: 4482745
• MDR Text Key: 5328818
• Report Number: 4482745
• Device Sequence Number: 1
• Product Code: IKY
• 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: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2015
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1