MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED ADULT DUAL HEATED BREATHING CIRCUIT; BTT

Model Number RT200

Device Problems Misassembled (1398); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A hospital in the (b)(6) reported to a fisher & paykel healthcare (fph) field representative that an rt200 adult dual heated breathing circuit had incomplete assembly.The insertion part for the 900mr869 airway temperature and flow probe was missing.This was observed before use on a patient.

Manufacturer Narrative

(b)(4).The complaint rt200 adult dual heated breathing circuit is en route to fisher & paykel healthcare in (b)(4) for investigation.We will provide a follow-up report once we have completed our investigation.

Manufacturer Narrative

(b)(4).Method: the complaint rt200 adult dual heated breathing circuit was returned to fph in (b)(4) and was visually inspected.Results: visual inspection revealed that the grommet and jacket probe were missing from the elbow of the inspiratory tube.A lot check revealed no other complaints of this nature for lot number 140225.Conclusion: we were unable to ascertain the specific root cause of the reported fault.All breathing circuits are pressure tested for leaks prior to distribution.Any breathing circuit which does not pass the pressure test is discarded.The subject rt200 adult breathing circuit would have met the required specification at the time of production.Our user instructions that accompany the rt200 adult dual heated breathing circuit state the following: "check all connections are tight before use." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "set appropriate ventilator alarm.".

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that an rt200 adult dual heated breathing circuit had incomplete assembly.The insertion part for the 900mr869 airway temperature and flow probe was missing.This was observed before use on a patient.

• Brand Name: ADULT DUAL HEATED BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine; 9494534000
• MDR Report Key: 4682950
• MDR Text Key: 5717045
• Report Number: 9611451-2015-00198
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 03/19/2015

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: RT200
• Device Catalogue Number: RT200
• Device Lot Number: 140225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 04/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2014
• 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