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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM, INC. AFFINITY 4 BED; BIRTHING BED

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HILL-ROM, INC. AFFINITY 4 BED; BIRTHING BED Back to Search Results
Model Number 3700
Device Problem Device Slipped (1584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/17/2014
Event Type  malfunction  
Event Description
Hill-rom received a report from the account stating when the brakes do not hold.The bed was located at the account in.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).
 
Manufacturer Narrative
The hill-rom technical support found the brake detent was 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 performs preventive maintenance on their beds.No further info is available on the repair of the bed at this time.If any additional relevant info is identified following completion of the repair , the additional relevant info will be submitted in a supplemental report.
 
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Brand Name
AFFINITY 4 BED
Type of Device
BIRTHING BED
Manufacturer (Section D)
HILL-ROM, INC.
batesville IN
Manufacturer Contact
john cummings
1069 state route 46 east
batesville, IN 47006
8129312869
MDR Report Key4436872
MDR Text Key17578658
Report Number1824206-2015-00080
Device Sequence Number1
Product Code HDD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K915779
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/17/2014
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 Number3700
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/17/2014
Initial Date FDA Received01/14/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2010
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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