FDA Adverse Event Malfunction Summary report: N

PORTABLE VIDEO MONITOR, GVL-2000

MDR report key: 2974069 · Received February 19, 2013

Report

Report Number
9615393-2013-00100
Event Type
Malfunction
Date Received
February 19, 2013
Date of Event
January 21, 2013
Report Date
January 21, 2013
Manufacturer
VERATHON MEDICAL (CANADA) ULC.
Product Code
CCW
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
IN, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. THE REPORTED INCIDENT COULD NOT BE CONFIRMED.

Description of Event or Problem · 1

THE CUSTOMER CONTACTED VERATHON INC. REGARDING A PORTABLE VIDEO MONITOR GVL-2000 THAT IS DIM WITH ALL BLADES. THE CUSTOMER TRIED TO CHANGE THE DIMNESS AND BRIGHTNESS ON THE MONITOR AND THE RESULTS WERE STILL THE SAME. NO INJURY TO THE PATIENT WAS REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
72446 PORTABLE VIDEO MONITOR, GVL-2000 NONE CCW VERATHON MEDICAL (CANADA) ULC. 0231-0003

Patients

Seq Age Sex Outcome Treatment
1