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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM, INC. AFFINITY THREE BED; BIRTHING BED
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HILL-ROM, INC. AFFINITY THREE BED; BIRTHING BED Back to Search Results
Model Number 3700
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2014
Event Type  malfunction  
Event Description
Hill-rom received a report from the account stating the brakes were defective.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as (b)(4).
 
Manufacturer Narrative
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.No further information is available on the repair of the bed at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
 
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Brand Name
AFFINITY THREE 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 Key4121905
MDR Text Key4940141
Report Number1824206-2014-02052
Device Sequence Number1
Product Code KNC
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K915779
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Unknown
Type of Report Initial
Report Date 07/02/2014
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 07/02/2014
Initial Date FDA Received07/31/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2009
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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