FDA Adverse Event Malfunction Summary report: N

RESPIRATORY HUMIDIFIER

MDR report key: 1565039 · Received November 17, 2009

Report

Report Number: 9611451-2009-00664
Event Type: Malfunction
Date Received: November 17, 2009
Report Date: November 20, 2009
Manufacturer: FISHER & PAYKEL HEALTHCARE, LTD.
Product Code: BTT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4) THE HC550 RESPIRATORY HUMIDIFIER IS NOT SOLD IN THE U.S., BUT IS SIMILAR TO A PRODUCT THAT IS SOLD IN THE U.S. THE 510(K) NUMBER OF THE SIMILAR PRODUCT IS K033710. METHOD: THE HC550 RESPIRATORY HUMIDIFIER AND ASSOCIATED (B)(4) TEMPERATURE PROBE WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4). THE HUMIDIFIER WAS RUN AND TESTED IN ACCORDANCE WITH THE PRODUCT TECHNICAL MANUAL. THE ASSOCIATED TEMPERATURE PROBE WAS ALSO TESTED IN ACCORDANCE WITH THE TECHNICAL MANUAL. RESULTS: THE HUMIDIFIER AND TEMPERATURE PROBE FUNCTIONED PROPERLY AND PASSED ALL PERFORMANCE TESTS. CONCLUSION: NO FAULT WAS FOUND WITH THE RETURNED HUMIDIFIER OR TEMPERATURE PROBE AS THE DEVICES FUNCTIONED PROPERLY DURING TESTING AND PASSED ALL PERFORMANCE TESTS.

Description of Event or Problem · 1

A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT AN HC550 RESPIRATORY HUMIDIFIER OVERHEATS. NO PT CONSEQUENCE WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RESPIRATORY HUMIDIFIER		BTT	FISHER & PAYKEL HEALTHCARE, LTD.	HC550	061003

Patients

Seq	Age	Sex	Outcome	Treatment
1				FISHER & PAYKEL HEALTHCARE (B)(4)\| TEMPERATURE PROBE