MAUDE Adverse Event Report: RECOVERCARE, LLC; AIR MATTRESS

Model Number 3649-5

Device Problems Air Leak (1008); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 01/06/2015

Event Type  malfunction  

Event Description

A patient was resting on recover care bariatric bed when the device experienced air loss.The surface is bottomed out under the patient's sacrum.

• Type of Device: AIR MATTRESS
• Manufacturer (Section D): RECOVERCARE, LLC; 2100 design rd; arlington , TX 76014
• MDR Report Key: 4529999
• MDR Text Key: 15353194
• Report Number: 4529999
• Device Sequence Number: 1
• Product Code: FNM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 01/15/2015

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
• Device Model Number: 3649-5
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR