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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 Problem Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/13/2014
Event Type  malfunction  
Event Description
The account reported the right side rail was not latching and the side rail was hanging off the bed from the mounting bracket.The bed was located in 6n at the facility.There was no pt/user injury reported.(b)(4).
 
Manufacturer Narrative
The tech found the side rail center arm assembly is broken.The tech does not know how the bed had gotten damaged but appears that the bed was ran into a doorway or from transport damage.The tech replaced the right side rail center arm assembly 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
jennifer morris
1069 state route 46 e
batesville, IN 47006
8129313121
MDR Report Key3845120
MDR Text Key4408014
Report Number1824206-2014-00838
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,Company Representative
Reporter Occupation Unknown
Type of Report Initial
Report Date 02/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2014
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
Date Manufacturer Received02/13/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2011
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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