MAUDE Adverse Event Report: HILL ROM, INC. HILL ROM TOTALCARE BARIATRIC PLUS; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number PR1840A000001

Device Problems Loss of Power (1475); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2014

Event Type  malfunction  

Event Description

Patient was in supine reverse due to being in full spine precautions and had slid down in the bed.Patient was placed flat in order to move patient up in bed.Bed raised itself higher in order to become flat.Once bed was horizontal and patient flat, bed lost power.Bed plugs were checked and rechecked by several nurses, who were already in room for repositioning.The bed plugs/cords were replugged into different red outlets.All attempts to regain electrical power were unsuccessful.Patient transferred to another bed.

• Brand Name: HILL ROM TOTALCARE BARIATRIC PLUS
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 3879537
• MDR Text Key: 4510329
• Report Number: 3879537
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: PR1840A000001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2014
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO.
• Patient Age: 57 YR
• Patient Weight: 159