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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 HOSP BED
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HILL-ROM, INC. VERSACARE BED; A/C POWERED ADJUSTABLE HOSP BED Back to Search Results
Model Number 3200
Device Problems Device Alarm System (1012); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/23/2014
Event Type  malfunction  
Event Description
Hill-rom received a report from a hill-rom tech stating the bed exit alarm was not making an audible sound.The bed was located in the bed shop.There was no pt/user injury reported.(b)(4).
 
Manufacturer Narrative
The hill-rom technician found the external piezo alarm needed to be replaced.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2009, 2012 and 2013.It is unk if the facility performed any other preventative maintenance on this bed.The tech replaced the external piezo 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 HOSP BED
Manufacturer (Section D)
HILL-ROM, INC.
batesville IN
Manufacturer Contact
lori daulton
1069 state route 46 e
batesville, IN 47006
8129312280
MDR Report Key3882780
MDR Text Key4595163
Report Number1824206-2014-00555
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 01/23/2014
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? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/23/2014
Initial Date FDA Received02/20/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2004
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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