MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT; BTT

Model Number RT319

Device Problems Fluid/Blood Leak (1250); Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2015

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) representative that an rt319 adult breathing circuit started to leak after one day of use.They further reported a cut on the circuit.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The rt319 adult 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 k983112.Method: the complaint rt319 adult breathing circuit was returned to fisher & paykel healthcare where it was visually inspected.Results: visual inspection revealed a cut over 53 cm on the inspiratory limb.A lot check revealed no other complaints of this nature for lot 140709.Conclusion: based on the damaged observed on the returned rt319 adult breathing circuit it is likely the circuit was cut with a sharp object.All breathing circuits are pressure tested for leaks prior to being released for distribution.Any circuits that fail are rejected.This suggests that the returned rt319 adult breathing circuit was damaged after it was released for distribution.The user instructions accompanied by the rt319 adult breathing circuit state: -"before connecting to patient, ensure that flow and pressure testing applicable to the ventilator has been completed." -"set appropriate ventilator alarms.".

• Brand Name: BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 4518233
• MDR Text Key: 5442708
• Report Number: 9611451-2015-00084
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT319
• Device Catalogue Number: RT319
• Device Lot Number: 140709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2015
• Initial Date Manufacturer Received: 01/24/2015
• Initial Date FDA Received: 02/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FPH 900MR801 HEATERWIRE ADAPTOR; FPH MR850 RESPIRATORY HUMIDIFIER; FPH 900MR869 TEMPERATURE PROBE; RESPIRONICS V60 VENTILATOR