MAUDE Adverse Event Report: JOERNS HEALTHCARE, INC RECOVERAIR 3000; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number RA3000

Device Problems Deflation Problem (1149); Failure to Power Up (1476); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2016

Event Type  malfunction  

Event Description

Patient transferred from chair back to bed.Ra3000 bed deflated suddenly.All plugs were plugged in.The lights on the bed for the alarm were lit.The pump at the end of the bed would not turn on.Recover care notified.Bed removed from service.No patient harm.

• Brand Name: RECOVERAIR 3000
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): JOERNS HEALTHCARE, INC; 2100 design rd.; arlington TX 76014
• MDR Report Key: 6259884
• MDR Text Key: 65103181
• Report Number: 6259884
• 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
• Type of Report: Initial
• Report Date: 11/25/2016

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: No Information
• Device Model Number: RA3000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/25/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR