MAUDE Adverse Event Report: RECOVERCARE, LLC RECOVERCARE; THERAPEUTIC BED PUMP

Model Number RECOVERAIR 3000 ELITE

Device Problems Failure to Power Up (1476); Failure to Pump (1502)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2015

Event Type  malfunction  

Event Description

The patient received a recovercare bed but the air pump would not turn on.The bed would not inflate with air.Recovercare maintenance was called.The pump was confirmed as broken and was replaced by the manufacturer rep.

• Brand Name: RECOVERCARE
• Type of Device: THERAPEUTIC BED PUMP
• Manufacturer (Section D): RECOVERCARE, LLC; 2100 design rd; arlington, TX 76014
• MDR Report Key: 5010587
• MDR Text Key: 23267998
• Report Number: 5010587
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/07/2015

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
• Device Operator: Nurse
• Device Model Number: RECOVERAIR 3000 ELITE
• Device Catalogue Number: RA3000
• Device Lot Number: 460859
• Other Device ID Number: PUMP 409908
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 48