FDA Adverse Event Summary report: N

MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

MDR report key: 4060480 · Received September 4, 2014

Report

Report Number
1531186-2014-03798
Date Received
September 4, 2014
Report Date
August 11, 2014
Manufacturer
C.T.M. TAIWAN
Product Code
INI
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

PER PROVIDER, UNIT HAS A FAULTY PCB.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
542207 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. TAIWAN PEGASUS4R-8

Patients

Seq Age Sex Outcome Treatment
1 Other