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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); Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/04/2014
Event Type  malfunction  
Event Description
Hill-rom received a report from a hill-rom technician stating the bed exit alarm would operate intermittently.The bed was located at the account in 936 e.There was no pt/user injury reported.This report was filed in our complaint handling sys as complaint #(b)(4).
 
Manufacturer Narrative
The hill-rom technician found the external alarm 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 performed any other preventive maintenance on their beds.The technician 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 HOSP BED
Manufacturer (Section D)
HILL-ROM, INC.
batesville IN
Manufacturer Contact
john cummings
1069 state route 46 east
batesville, IN 47006
8129312869
MDR Report Key4321186
MDR Text Key5129184
Report Number1824206-2014-02733
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
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 11/04/2014
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 11/04/2014
Initial Date FDA Received12/02/2014
Was Device Evaluated by Manufacturer? Yes
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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