INFANT BIAS FLOW DUAL HEATED WITH EVAQUA BREATHING CIRCUIT

Report

Report Number: 9611451-2010-00742
Event Type: Malfunction
Date Received: December 12, 2010
Date of Event: November 5, 2010
Report Date: November 16, 2010
Manufacturer: FISHER & PAYKEL HEALTHCARE LIMITED
Product Code: BZE
PMA / PMN Number: K034026
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE RT235 INFANT BIAS FLOW DUAL HEATED WITH EVAQUA BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

Additional Manufacturer Narrative · 1

(B)(4). THE HEALTHCARE FACILITY REPORTED TO FPH QUALITY/REGULATORY ASSISTANT IN (B)(6) THAT THIS INCIDENT IS SIMILAR TO THE INCIDENT REPORTED TO FDA UNDER MFR REPORT # 9611451-2010-00734. A FOLLOW-UP REPORT WITH DEVICE EVALUATION RESULT WILL BE SENT UNDER THE SAID MFR REPORT #.

Description of Event or Problem · 1

A HEALTHCARE FACILITY REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT235 INFANT BIAS FLOW DUAL HEATED WITH EVAQUA BREATHING CIRCUIT FAILED THE SERVO-I VENTILATOR LEAK TEST. THIS WAS NOTICED BEFORE USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

Description of Event or Problem · 1

A HEALTHCARE FACILITY REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT235 INFANT BIAS FLOW DUAL HEATED WITH EVAQUA BREATHING CIRCUIT FAILED THE SERVO-I VENTILATOR LEAK TEST. THIS WAS NOTICED BEFORE USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFANT BIAS FLOW DUAL HEATED WITH EVAQUA BREATHING CIRCUIT	BZE	BZE	FISHER & PAYKEL HEALTHCARE LIMITED	RT235	100609

Patients

Seq	Age	Sex	Outcome	Treatment
1