MAUDE Adverse Event Report: JOERNS HEALTHCARE, INC. AUTO VECTOR RA FROM RECOVER CARE ASSET # 732407; BED, BARIATRIC

Device Problems Material Integrity Problem (2978); Pressure Problem (3012)

Patient Problem No Code Available (3191)

Event Date 08/16/2014

Event Type  Injury  

Event Description

Pt on "dolphin" immersion mattress.Bottomed out, resting on metal bed frame.Caregiver had product rep come in at 0300 hrs to check mattress, he increased the inflation, but at this time, pt is on the metal frame again.Called in equipment to have it replaced stat with fluid air bed.Have part of tag where recover care employee who came in at 0300 hrs wrote on back that this was raav dolphin.Obtained regular and bariatric seat cushions and placed under pt.To try to provide some presure redistribution.

• Brand Name: AUTO VECTOR RA FROM RECOVER CARE ASSET # 732407
• Type of Device: BED, BARIATRIC
• Manufacturer (Section D): JOERNS HEALTHCARE, INC.; 2100 design rd; arlington TX 76014
• MDR Report Key: 4293326
• MDR Text Key: 5082623
• Report Number: 4293326
• Device Sequence Number: 1
• Product Code: FNL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2014
• Patient Sequence Number: 1
• Patient Age: 57 YR