MAUDE Adverse Event Report: HILL-ROM BATESVILLE VERSACARE FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P3200J000040

Device Problem Device Slipped (1584)

Patient Problem No Patient Involvement (2645)

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the brake caster 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.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 (b)(6) 2018.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the brake caster to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from a hill-rom technician stating the bed brakes were not holding.The bed was located 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: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: shawn flannery ; 1069 state route 46 east; batesville, IN 47006
• MDR Report Key: 8112099
• MDR Text Key: 128735244
• Report Number: 1824206-2018-00455
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: P3200J000040
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2010
• 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