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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM, INC. ADVANTA BED; A/C POWERED ADJUSTABLE HOSPITAL BED

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HILL-ROM, INC. ADVANTA BED; A/C POWERED ADJUSTABLE HOSPITAL BED Back to Search Results
Model Number 1600
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/15/2015
Event Type  malfunction  
Manufacturer Narrative
The hill-rom technician found the bed exit sensor strips inoperable.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The account replaced bed exit sensor strips to resolve the issue.Based on this information, no further action is required.
 
Event Description
Hill-rom received a report from the account stating the bed exit alarm was inaudible.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).
 
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Brand Name
ADVANTA BED
Type of Device
A/C POWERED ADJUSTABLE HOSPITAL BED
Manufacturer (Section D)
HILL-ROM, INC.
batesville IN
Manufacturer Contact
john cummings
1069 state route 46 east
batesville, IN 47006
8129312869
MDR Report Key4992668
MDR Text Key23221160
Report Number1824206-2015-00788
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
Reporter Occupation Other
Report Date 07/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number1600
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received07/15/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2003
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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