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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM, INC. VERSACARE BED; A/C POWERED ADJUSTABLE HOSPITAL BED
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HILL-ROM, INC. VERSACARE BED; A/C POWERED ADJUSTABLE HOSPITAL BED Back to Search Results
Model Number 3200
Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/08/2015
Event Type  malfunction  
Event Description
Hill-rom received a report from a hill-rom technician stating the bed was moving on its own.The bed was located at the account in room 108.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).
 
Manufacturer Narrative
The hill-rom technician found a wire in the hand pendant damaged.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2008, 2009, 2011-2014.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the hand pendant to resolve the issue.Based on this information, no further action is required.
 
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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 east
batesville, IN 47006
8129312869
MDR Report Key4759784
MDR Text Key5777978
Report Number1824206-2015-00562
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
Reporter Occupation Other
Type of Report Initial
Report Date 04/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number3200
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/08/2015
Initial Date FDA Received05/04/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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