FDA Adverse Event Summary report: N

MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

MDR report key: 4187498 · Received October 21, 2014

Report

Report Number
1531186-2014-04970
Date Received
October 21, 2014
Date of Event
September 30, 2014
Report Date
September 30, 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 BRAKES NOT WORKING (MOTOR (12 KM/H) RHINO 2 9153654155). ADDITIONAL ASSOCIATED REPORTABLE MALFUNCTION - PER PROVIDER BRAKES NOT WORKING (CONTROLLER, RHINO 2 (110A) PEGASUS 9153653519).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
666853 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. TAIWAN PEGASUS3S-8

Patients

Seq Age Sex Outcome Treatment
1 Other