FDA Adverse Event Malfunction Summary report: N

RANGER MONITOR W/SNAPS, LARGE & POWER SUPPLY

MDR report key: 3000151 · Received February 14, 2013

Report

Report Number: 9615393-2013-00057
Event Type: Malfunction
Date Received: February 14, 2013
Date of Event: January 14, 2013
Report Date: January 16, 2013
Manufacturer: VERATHON MEDICAL (CANADA) ULC.
Product Code: CCW
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

SERVICE RECEIVED THE DEVICE FOR FURTHER EVALUATION. SERVICE PLUGGED IN A TEST BATON TO THE RANGER MONITOR AND POWERED IT ON. THE MONITOR LCD WAS ON BUT THERE WAS NO IMAGE. THE REPORTED FAILURE WAS CONFIRMED. FURTHER EVALUATION OF THE DEVICE SHOWED THAT A FAULTY INPUT CONNECTOR IS THE CAUSE OF THE REPORTED FAILURE. THE INPUT CONNECTOR WAS REPLACED.

Description of Event or Problem · 1

THE CUSTOMER CONTACTED VERATHON INC. REGARDING A GLIDESCOPE RANGER MONITOR THAT HAS NO VIDEO AND THE BATON NOT LIGHTING UP. THE CUSTOMER WAS USING THE DEVICE ON A TRAUMA PATIENT ON (B)(6) 2013. THE CUSTOMER SWITCHED THE MONITOR ON BUT THE MONITOR DID NOT TURN ON. THE CUSTOMER STOPPED USING THE GLIDESCOPE AND WENT TO A STANDARD INTUBATION WITH DIFFERENT EQUIPMENT. THE CUSTOMER USED A (B)(4) BLADE TO INTUBATE THE PATIENT AND THE INTUBATION WAS SUCCESSFUL. THE PATIENT IS STABLE BUT IN GUARDED CONDITION (STILL IN HOSPITAL). DURING TROUBLESHOOTING WITH THE CUSTOMER DIFFERENT BATONS WERE USED AND STILL NO VIDEO OR LIGHT ON THE BATON. THE CUSTOMER WAS ORDERED TO SEND THE MONITOR FOR FURTHER EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
65384	RANGER MONITOR W/SNAPS, LARGE & POWER SUPPLY	NONE	CCW	VERATHON MEDICAL (CANADA) ULC.	0270-0424

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization