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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM PLUVIGNER CARE ASSIST BED; A/C POWERED ADJUSTABLE HOSPITAL BED
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HILL-ROM PLUVIGNER CARE ASSIST BED; A/C POWERED ADJUSTABLE HOSPITAL BED Back to Search Results
Model Number 1170
Device Problems Device Alarm System (1012); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2015
Event Type  malfunction  
Event Description
Hill-rom received a report from a hill-rom tech stating the brakes not set alarm was not working.The bed was located on 2nd floor micu hallway 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 tech found the brake switch was broken.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed from 2013-2014.It is unk if the facility performed any other preventative maintenance on this bed.The tech replaced the brake switch to resolve the issue.Based on this info, no further action is required.
 
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Brand Name
CARE ASSIST BED
Type of Device
A/C POWERED ADJUSTABLE HOSPITAL BED
Manufacturer (Section D)
HILL-ROM PLUVIGNER
pluvigner
FR 
Manufacturer Contact
tony werner
1069 state rte 46 e
batesville, IN 47006
8129312359
MDR Report Key4838144
MDR Text Key5932563
Report Number9615739-2015-00190
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 05/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number1170
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/14/2015
Was Device Evaluated by Manufacturer? Yes
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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