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

Model Number 3200

Device Problem Locking mechanism failure (2593)

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

Event Date 02/12/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the brakes were not holding (right head break steer pedal would not lock the brakes or set the steer).The bed was located in the storage area at the account.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint number (b)(4).

Manufacturer Narrative

The tech found the bolt on the brake for the brake/steer arm was loose causing the brake/steer pedal to disconnect from the torque tube.Per the hill-rom service manual, perform annual preventative maintenance procedures to make sure all versacare bed components are functioning as originally designed.Brake casters should be checked for cuts, wear and quality of tread, etc.And replaced when necessary.Examine the brakes to see whether the bed moves when the brake are set.Replace as necessary.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2012 and 2013.It is unk if the facility performed any other preventative maintenance on this bed.The tech reconnected the brake/steer pedal to the torque tube and tightened the bolt on the brake/steer arm to resolve the issue.Based on this info, no further action is required.

• Brand Name: VERSACARE BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN 47006
• Manufacturer (Section G): HILL-ROM, INC.; 1069 state route 46 e; batesville IN 47006
• Manufacturer Contact: lori daulton ; 1069 state route 46 e; batesville, IN 47006 ; 8129312280
• MDR Report Key: 3727846
• MDR Text Key: 4308340
• Report Number: 1824206-2014-00806
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2005
• 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