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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM, INC. VERSACARE; BED, FLOTATION THERAPY, POWERED
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HILL-ROM, INC. VERSACARE; BED, FLOTATION THERAPY, POWERED Back to Search Results
Model Number P3200K000500
Device Problem Device Alarm System (1012)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 03/15/2017
Event Type  Injury  
Event Description
Patient in bed and alarm was set by nurse on least sensitive setting to allow the patient to sit on the edge of the bed for breakfast.The patient had previously tried to get up and the alarm had alerted staff.This is a semiprivate room and the nurse was talking to the patient in the other bed when she saw the patient begin to walk around the curtain between the patients.The patient fell straight back striking the floor.The alarm did not activate when the patient stood up.The patient was recovering from a hip fracture.This fall resulted in a secondary fracture (non-surgical) to the right femur.
 
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Brand Name
VERSACARE
Type of Device
BED, FLOTATION THERAPY, POWERED
Manufacturer (Section D)
HILL-ROM, INC.
1069 state route 46 east
batesville IN 47006
MDR Report Key6868314
MDR Text Key86288619
Report Number6868314
Device Sequence Number1
Product Code IOQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/31/2017,09/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Model NumberP3200K000500
Other Device ID NumberM05093200K0005005
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/31/2017
Device Age4 YR
Event Location Hospital
Date Report to Manufacturer03/31/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
Patient Outcome(s) Other;
Patient Age72 YR
Patient Weight56
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