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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM ADVANTA ELECTRIC HOSPITAL BED

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HILL-ROM ADVANTA ELECTRIC HOSPITAL BED Back to Search Results
Model Number P1600
Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Patient Problems Fall (1848); Hip Fracture (2349)
Event Date 04/14/2017
Event Type  Injury  
Event Description
After pt returned from ambulating to the restroom, he leaned on his hospital bed to get back into bed. The bed then slid back, and he fell to the floor on his left side, sustaining an abrasion on his left elbow. The next day, he was unable to bear weight on his left leg, and imaging tests indicated an acute fracture to his left hip. Surgical intervention not recommended at this time. Referred to a rehab facility for initial pt. (b)(4) inspected suspected device. During testing, brakes were locked with casters adjusted in various positions, then a significant amount of pressure was applied to several locations on the bed's weigh frame side (head, intermediate, and foot sections) while in the high-low-high and low-high and low positions. Simulated a patient entering and exiting the bed with the bed in the lowest position and brakes in the lock position. It was concluded that when the brake function was engaged, the brakes worked as designed. No defects were found from the reported complaint, and no repairs were required nor recommended.
 
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Brand NameADVANTA
Type of DeviceELECTRIC HOSPITAL BED
Manufacturer (Section D)
HILL-ROM
batesville IN
MDR Report Key6576678
MDR Text Key75524559
Report Number6576678
Device Sequence Number1
Product Code FNJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberP1600
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/28/2017
Distributor Facility Aware Date04/14/2017
Device Age15 YR
Event Location Hospital
Date Report to Manufacturer04/28/2017
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/05/2017 Patient Sequence Number: 1
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