INFANT LOW FLOW BREATHING CIRCUIT

Report

Report Number: 9611451-2012-00720
Event Type: Malfunction
Date Received: October 8, 2012
Date of Event: September 13, 2012
Report Date: September 14, 2012
Manufacturer: FISHER & PAYKEL HEALTHCARE LIMITED
Product Code: BTT
PMA / PMN Number: SEE H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). LOT NUMBER: 120315, 120430; MANUFACTURING DATE: 03/15/2012, 04/30/2012; QUANTITY AFFECTED: (B)(4). THE RT226 INFANT LOW FLOW BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. THE COMPLAINT BREATHING CIRCUITS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

Additional Manufacturer Narrative · 1

(B)(4). LOT NUMBER: MANUFACTURING DATE: QUANTITY AFFECTED: 120315, 03/15/2012, 1. 120430, 04/30/2012, 1. THE RT226 INFANT LOW FLOW BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. THE COMPLAINT INFANT BREATHING CIRCUITS WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WITHOUT THE COMPLAINT DEVICES WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAULT.

Description of Event or Problem · 1

A HOSPITAL IN (B)(6) REPORTED TO A DISTRIBUTOR THAT TWO RT226 INFANT LOW FLOW BREATHING CIRCUITS EACH HAD A FAULTY HEATER WIRE ADAPTER. NO PATIENT CONSEQUENCE WAS REPORTED.

Description of Event or Problem · 1

A HOSPITAL IN (B)(6) REPORTED TO A DISTRIBUTOR THAT TWO RT226 INFANT LOW FLOW BREATHING CIRCUITS EACH HAD A FAULTY HEATER WIRE ADAPTER. NO PATIENT CONSEQUENCE WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFANT LOW FLOW BREATHING CIRCUIT	BTT	BTT	FISHER & PAYKEL HEALTHCARE LIMITED	RT226

Patients

Seq	Age	Sex	Outcome	Treatment
1