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

Model Number 3200

Device Problems Device Alarm System (1012); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2015

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the brakes not set alarm was inoperable.The bed was located at the account in 6n.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The hill-rom technician found the external alarm inoperable.Per the hill-rom service manual, perform annual preventive 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 2013-2015.It is unk if the facility performed any other preventative maintenance on this bed.Hill-rom technician replaced the external alarm 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
• Manufacturer Contact: john cummings ; 1069 state route 46 e; batesville, IN 47006 ; 8129312869
• MDR Report Key: 4748954
• MDR Text Key: 5770382
• Report Number: 1824206-2015-00557
• 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: Unknown
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 3200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• 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