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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 Unintended Head Motion (1284)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2014
Event Type  malfunction  
Event Description
The account reported the head up function has unintentional movement.There was no pt/user injury reported.(b)(4).
 
Manufacturer Narrative
The account stated they will isolate side rail cables to trouble shoot the issue.The account found the left side rail was the cause.No further info is available on the repair of the bed at this time.The investigation is ongoing, however if any add'l relevant info identified following completion of the investigation, the add'l relevant info 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 route 46 east
batesville, IN 47006
8129313121
MDR Report Key3783403
MDR Text Key4361853
Report Number1824206-2014-00988
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 02/26/2014
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 02/26/2014
Initial Date FDA Received03/25/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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