HEAVY DUTY TRAPEZE 200LB. PULL WEIGHT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-05 for HEAVY DUTY TRAPEZE 200LB. PULL WEIGHT manufactured by Mizuho / Hill-rom.

Event Text Entries

[3657735] A pt hospitalized at our facility following a total hip replacement was attempting to boost himself up in his bed with the help of hospital staff and a trapeze system attached to the bed. He pulled on the trapeze bar attached to the bed to assist in boosting him up and the trapeze came apart from the chain and he fell back into the bed with the trapeze bar hitting him in the chest. A "s hook" in the chain system on the trapeze malfunctioned when a chain link passed through the "s hook" causing the trapeze bar to release from the chain system and back at the pt. The pt experienced an injury to his shoulder and trapezius muscle which required physical therapy post hospitalization. One of the nursing staff that was assisting the pt with the boost in his bed also experienced an injury to her neck. She required an anterior fusion surgery on her neck which was caused by the pt's abrupt fall back in his bed when the trapeze bar came apart from the chain of the trapeze system on the bed. Reason for use: total hip replacement.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5030824
• MDR Report Key: 3221718
• Date Received: 2013-07-05
• Date of Report: 2013-06-28
• Date of Event: 2012-12-06
• Date Added to Maude: 2013-07-11
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HEAVY DUTY TRAPEZE 200LB. PULL WEIGHT
• Generic Name: TRAPEZE SYSTEM
• Product Code: FMR
• Date Received: 2013-07-05
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MIZUHO / HILL-ROM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2013-07-05