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

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.

• Brand Name: ADVANTA
• Type of Device: ELECTRIC HOSPITAL BED
• Manufacturer (Section D): HILL-ROM; batesville IN
• MDR Report Key: 6576678
• MDR Text Key: 75524559
• Report Number: 6576678
• Device Sequence Number: 1
• Product Code: FNJ
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P1600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2017
• Distributor Facility Aware Date: 04/14/2017
• Device Age: 15 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR