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 |