FDA Adverse Event Malfunction Summary report: N

880 HUMIDIFICATION SYSTEM

MDR report key: 1610134 · Received February 15, 2010

Report

Report Number: 9611451-2010-00047
Event Type: Malfunction
Date Received: February 15, 2010
Date of Event: January 4, 2010
Report Date: January 8, 2010
Manufacturer: FISHER & PAYKEL HEALTHCARE LTD.
Product Code: BTT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS DEVICE IS NOT SOLD IN THE USA, BUT SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510 (K) FOR THAT PRODUCT IS K073706. METHOD: THE RETURNED CIRCUIT WAS TESTED TO SEE IF IT COULD BE CONNECTED TO A HEATER WIRE ADAPTOR. RESULTS: THE HEATER WIRE ADAPTOR COULD NOT BE CONNECTED TO THE HEATER WIRE SOCKET IN THE INSPIRATORY LIMB. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: ALL BREATHING CIRCUITS ARE TESTED FOR ELECTRICAL CONNECTION AND CONTINUITY DURING PRODUCTION. IT IS POSSIBLE FOR THE USER TO DAMAGE THE HEATER WIRE PINS IF THE HEATER WIRE ADAPTOR IS INSERTED INTO THE HEATER WIRE PLUG ON AN ANGLE. FOR BENT OR DAMAGED PINS REPORTED TO US BY HEALTHCARE FACILITIES, IT IS IMPOSSIBLE FOR US TO DETERMINE WHETHER THE PINS WERE DAMAGED DURING PRODUCTION OR BY THE END USER. BENT OR DAMAGED PINS DO NOT PRECLUDE VENTILATION OF THE PATIENT, BUT PREVENT THE HEATING OF THE GAS DELIVERED. (B)(4).

Description of Event or Problem · 1

A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT A BREATHING CIRCUIT OF AN RT241 880 HUMIDIFICATION SYSTEM COULD NOT BE INSERTED INTO THE HEATER WIRE ADAPTOR PLUG DUE TO MISALIGNED PINS ON THE BREATHING CIRCUIT. THIS FAULT WAS NOTICED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	880 HUMIDIFICATION SYSTEM	NONE	BTT	FISHER & PAYKEL HEALTHCARE LTD.	RT241	090922

Patients

Seq	Age	Sex	Outcome	Treatment
1