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U.S. Department of Health and Human Services

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

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HILL-ROM BATESVILLE VERSACARE FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number P3200J000492
Device Problem Device Slipped (1584)
Patient Problem No Patient Involvement (2645)
Event Date 12/17/2019
Event Type  malfunction  
Manufacturer Narrative
The hillrom technician found the left foot steer caster needed to be replaced.Per the hillrom 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 hillrom maintenance records showed hillrom performed preventative maintenance on this bed in february 2019.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the left foot steer caster to resolve the issue.Based on this information, no further action is required.
 
Event Description
Hillrom received a report from a hillrom technician stating the bed's left foot steer caster was 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).
 
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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
lori daulton
1069 state route 46 east
batesville, IN 47006
8129312280
MDR Report Key9526391
MDR Text Key191473200
Report Number1824206-2019-00535
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial
Report Date 12/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberP3200J000492
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/25/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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