MAUDE Adverse Event Report: HILL-ROM, INC. TOTALCARE BED; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number 1900

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Skin Tears (2516)

Event Date 01/31/2014

Event Type  Other  

Event Description

The consumer reported skin breakdown on the total care bed.No further details were given.The bed is located in the pt's home.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The hill-rom rep spoke with the wife of the pt and she stated that her husband, who is the pt, has been on this unit for approx four years and was in an accident six years ago, causing him to need the totalcare unit.The wife stated that her husband's condition is getting worse.He currently has a stage level 3 open wound on his buttocks from the seat area of the mattress not properly inflating.She said she and the nurse make him stand up and move around often to help relieve the pressure on his body in hopes of the pressure ulcer not turning into a stage level 4.She stated that she felt like the unit was working well but continues to deflate in the seat area only.She said the mattress is owned by the (b)(4) but she is going to call hill-rom customer service for a mattress replacement.The tech investigated the alleged incident and checked all the functions of the bed and mattress and found when the bed is in marx inflate, the mattress seems fine, but in normal mode, the mattress has a sunken area in the seat.The tech did not find any cushions deflated but just an area that the pt sinks into.Pt is in the bed twenty four hours a day.The tech did not troubleshoot the mattress further and he suggested to the customer that the mattress should be replaced.

• Brand Name: TOTALCARE BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 state route 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3671935
• MDR Text Key: 4339920
• Report Number: 1824206-2014-00667
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Type of Report: Initial
• Report Date: 01/31/2014

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: Other
• Device Model Number: 1900
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/31/2014
• Initial Date FDA Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 68