FDA.reportPublic FDA data

MAUDE MDR 558602

MDR report key
558602
Report number
MW1033628
Event key
0
Event type
3
Date of event
2002-01-21
Date received
2004-10-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BRAUNVANGATOR II*ING***NR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-10-1401. H; 2. R

Event Narratives#

D

Patient 1

BRAUN VANGATORII WHEELCHAIR LIFT MALFUNCTIONED GOING INTO THE STOW POSITION OUT OF SEQUENCE THROWING THE PT ONTO THE FLOOR OF THEIR VAN WITH THEIR WHEELCHAIR LANDING ON TOP OF THEM. DURING THEIR INVESTIGATION THEY HAVE DISCOVERED THIS PRODUCT HAS BEEN RECALLED TWICE BEFORE AND OUT OF 32 OTHER USERS INDENTIFIED BY THEIR EXPERT WITNESS 4 OTHERS HAD THE SAME PROBLEM AS PT EXPERIENCED, A PREMATURE FOLDING ON THE LIFT. THE MFR TOOK THE PRODUCT BACK, EVALUATED THE PRODUCT FINDING BURNT WIRES AND DESTROYED THE EVIDENCE. PT BELIEVES A 12% FAILURE RATE IS TOO HIGH AND REQUESTS INTERVENTION BEFORE OTHERE ARE HURT AS BADLY AS THEY WERE. IN ADDITON PT WILL ADD THAT OUT OF THEIR FINDINGS 72% OF THE OTHER USERS EXPERIENCED FAILURES OF THIS TYPE OR OTHERS LEAVING THEM STRANDED IN THEIR WHEELCHAIRS.