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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 Known Impact Or Consequence To Patient (2692)
Event Date 01/21/2015
Event Type  malfunction  
Event Description
Hill-rom received a report from the account stating the brakes were not holding.The bed was located in a patient room at the account.There was no patient/user injury reported.(b)(4).
 
Manufacturer Narrative
Hill-rom technical support suggested replacing the brake detent.A search of the hill-rom maintenance records did not show hill-rom performed any preventive maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The account replaced the brake detent top to resolve the issue.Based on this information, 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
tony werner
1069 state route 46 east
batesville, IN 47006
8129312359
MDR Report Key4539285
MDR Text Key20788363
Report Number1824206-2015-00243
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 01/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2015
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 Received01/21/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2010
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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