FDA Adverse Event Malfunction Summary report: N

GLIDESCOPE RANGER MONITOR

MDR report key: 3000153 · Received February 14, 2013

Report

Report Number
9615393-2013-00059
Event Type
Malfunction
Date Received
February 14, 2013
Date of Event
January 16, 2013
Report Date
January 16, 2013
Manufacturer
VERATHON MEDICAL (CANADA) ULC.
Product Code
CCW
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
PA, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

SERVICE RECEIVED THE DEVICE FOR FURTHER EVALUATION. SERVICE CONFIRMED THE FAILURE AND FOUND A FAULTY INPUT CONNECTOR ON THE MONITOR SERVICE REPLACED THE BACK SHELL ASSEMBLY AND THE FAULTY INPUT CONNECTOR.

Description of Event or Problem · 1

THE CUSTOMER CONTACTED VERATHON INC. REGARDING A GLIDESCOPE RANGER MONITOR DEVICE THAT HAS A CABLE CONNECTOR OR THAT IS DAMAGED. THE DAMAGED CONNECTOR IS NOT ALLOWING A BATON OR A BLADE TO BE CONNECTED TO THE MONITOR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
64567 GLIDESCOPE RANGER MONITOR NONE CCW VERATHON MEDICAL (CANADA) ULC. M570-0186

Patients

Seq Age Sex Outcome Treatment
1