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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM INC. AFFINITY 4 BIRTHING BED
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HILL-ROM INC. AFFINITY 4 BIRTHING BED Back to Search Results
Model Number 3700
Device Problem Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2014
Event Type  malfunction  
Event Description
The account reported the brake casters keep coming out of brake mode.The brake engages but once the bed is pushed the brakes pop out of brake mode.The bed is located in the bed shop at the facility.There was no pt/user injury reported.(b)(4).
 
Manufacturer Narrative
The account troubleshot with hill-rom technical support and they believe the brake detent is the cause of the issue.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 4 BIRTHING BED
Type of Device
BIRTHING BED
Manufacturer (Section D)
HILL-ROM INC.
batesville IN
Manufacturer Contact
jennifer morris
1069 state rt 46 east
batesville, IN 47006
8129313121
MDR Report Key4001990
MDR Text Key4775436
Report Number1824206-2014-01902
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 06/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2014
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
Date Manufacturer Received06/05/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2010
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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