BRAUN *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-10-14 for BRAUN * manufactured by *.

Event Text Entries

[313578] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1033628
• MDR Report Key: 558602
• Date Received: 2004-10-14
• Date of Report: 2004-10-14
• Date of Event: 2002-01-21
• Date Added to Maude: 2004-12-10
• 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: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BRAUN
• Generic Name: VANGATOR II
• Product Code: ING
• Date Received: 2004-10-14
• Returned To Mfg: 2004-01-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 548296
• Manufacturer: *
• Manufacturer Address: * * MN * US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2004-10-14