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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 Problem Alarm Not Visible (1022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/27/2014
Event Type  malfunction  
Event Description
Hill-rom received a report from the account stating there is no alarm for the bed exit.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).
 
Manufacturer Narrative
The hill-rom technical support found the external buzzer inoperable.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The account replaced the external buzzer assembly 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 Key4287232
MDR Text Key5053043
Report Number1824206-2014-02690
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 User Facility
Reporter Occupation Unknown
Type of Report Initial
Report Date 10/27/2014
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? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/27/2014
Initial Date FDA Received11/21/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2010
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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