MAUDE MDR 3221718

MDR report key
3221718
Report number
MW5030824
Event key
0
Event type
3
Date of event
2012-12-06
Date received
2013-07-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HEAVY DUTY TRAPEZE 200LB. PULL WEIGHTTRAPEZE SYSTEMMIZUHO / HILL-ROMFMR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-07-0501. R

Event Narratives#

D

Patient 1

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.