FDA Adverse Event Malfunction Summary report: N

ZOLL IVTM THERMOGARD XP

MDR report key: 4090831 · Received September 15, 2014

Report

Report Number: 3010617000-2014-00468
Event Type: Malfunction
Date Received: September 15, 2014
Date of Event: August 5, 2014
Report Date: August 6, 2014
Manufacturer: ZOLL CIRCULATION, INC
Product Code: NCX
PMA / PMN Number: K072234
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

THERMOGARD XP IVTM SYSTEM S/N (B)(4) WAS EVALUATED AT THE CUSTOMER'S SITE. VISUAL INSPECTION OF THE SYSTEM FOUND THE AIR FILTER AND AIR TRAP TO BE DIRTY. A REVIEW OF THE EVENT LOG WAS PERFORMED AND FOUND NO ERRORS OR ANOMALIES. PATIENT DATA WAS NOT PROVIDED TO ZOLL. THE SYSTEM UNDERWENT AND PASSED INITIAL FUNCTIONAL TESTING. THE SYSTEM WAS TURNED ON/OFF WITH NO PROBLEMS AND NO ERRORS OR ANOMALIES WERE EXHIBITED. NO PARTS WERE REPLACED TO REMEDY THE CUSTOMER'S REPORTED COMPLAINT. ADDITIONAL WORK COMPLETED NOT RELATED TO THE REPORTED COMPLAINT TO ENSURE THAT THE IVTM SYSTEM IS FUNCTIONING WITHOUT ISSUES: THE AIR FILTER AND AIR TRAP WERE CLEANED. THE SYSTEM UNDER WENT AND PASSED ALL FINAL FUNCTIONAL TESTING. THE CUSTOMER'S REPORTED COMPLAINT OF THE SYSTEM NOT COOLING THE PATIENT COULD NOT BE CONFIRMED, AS THE PATIENT DATA WAS NOT PROVIDED, THE SYSTEM FUNCTIONED AS INTENDED DURING INITIAL AND FINAL FUNCTIONAL TESTING AND THERE WERE NO ERRORS OR ANOMALIES NOTED IN THE EVENT LOG.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE IVTM THERMOGARD XP CONSOLE DID NOT COOL THE PATIENT. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
568682	ZOLL IVTM THERMOGARD XP	THERMAL REGULATING SYSTEM	NCX	ZOLL CIRCULATION, INC	8700-0650

Patients

Seq	Age	Sex	Outcome	Treatment
1