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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 3201
Device Problems No Audible Alarm (1019); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/27/2015
Event Type  malfunction  
Event Description
Hill-rom received a report from the account stating the brake not set alarm had no audible alarm.The bed was located at the account.There was no pt/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 alarm to be inoperable.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unk if the facility performs preventative maintenance on their beds.The account replaced the external alarm to resolve the issue.Based on this info, 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 rte 46 e
batesville, IN 47006
8129312869
MDR Report Key4862580
MDR Text Key5849676
Report Number1824206-2015-00669
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Reporter Country CodeTC
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 05/27/2015
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 Number3201
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/27/2015
Initial Date FDA Received06/18/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2014
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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