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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 Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/30/2015
Event Type  malfunction  
Event Description
Hill-rom received a report from the account stating the bed was raising the head section up on its own.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).
 
Manufacturer Narrative
The hill-rom tech support found the right caregiver board and patient inside board to be damaged.A search of hill-rom maintenance records did not show hill-rom performed any preventative maintenance on their beds.The account replaced the right caregiver board and patient inside board to resolve the issue.Based on this info, no further action is required.
 
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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 Key4809204
MDR Text Key5833946
Report Number1824206-2015-00618
Device Sequence Number1
Product Code KNC
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 04/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2015
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 Received04/30/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2011
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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