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

Model Number P3200K000679

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the brake switch needed to be replaced.Per the hill-rom service manual, perform annual preventive maintenance procedures to make sure all versacare® bed components are functioning as originally designed.Make sure the brake is not set, and then plug the bed into an applicable power source.A steady alarm comes on.Set the brake.The alarm stops.Repair or replace as necessary.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in july 2017.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the brake switch to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the bed's brake not set alarm was not working.The bed was located on the 4th floor at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint (b)(4).

• Brand Name: VERSACARE FRAME
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 7645100
• MDR Text Key: 112870938
• Report Number: 1824206-2018-00253
• 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: company representative,user f
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P3200K000679
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1