MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT266

Device Problem Hole In Material (1293)

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

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The three complaint rt266 breathing circuits will not be returned by the hospital facility for evaluation.We are currently in the process of obtaining further information from the hospital.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via an fisher & paykel healthcare (fph) representative that three rt266 infant dual-heated evaqua2 breathing circuits developed holes along the inspiratory limb seamline after 24 hours use.It was reported that the ventilator alarmed and the circuits were replaced.The three complaint rt266 breathing circuits will not be returned by the hospital facility for evaluation.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The three complaint rt266 breathing circuits will not be returned by the hospital facility for evaluation.We are currently in the process of obtaining further information from the hospital.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via an fisher & paykel healthcare (fph) representative that three rt266 infant dual-heated evaqua2 breathing circuits developed holes along the inspiratory limb seamline after 24 hours use.It was reported that the ventilator alarmed and the circuits were replaced.The three complaint rt266 breathing circuits will not be returned by the hospital facility for evaluation.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the three complaint rt266 infant dual-heated evaqua2 breathing circuits were not returned to fisher & paykel healthcare (fph) in (b)(4) for investigation as they were retained by the hospital facility.Photographs of the complaint breathing circuits were provided however attempts to obtain further information with regards to the reported event were unsuccessful.Therefore our investigation was carried out based on the photographs provided by the hospital facility and the results of previous investigations into similar complaints.Results: visual inspection of the provided photographs revealed cut-like damage to the inspiratory limb.Conclusion: without the return of the complaint devices, we are unable to definitively determine what may have caused the problem experienced by the customer.However, based on our knowledge of previous similar complaints, it is possible that this type of damage occurs from using a sharp tool (e.G.Boxcutter) when opening boxes or circuit kit bags.All rt266 infant dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specification prior to distribution.Our user instructions that accompany the rt266 infant dual heated evaqua2 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 alarms." "do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers.".

Event Description

A hospital in (b)(6) reported via an fisher & paykel healthcare (fph) representative that three rt266 infant dual-heated evaqua2 breathing circuits developed holes along the inspiratory limb seamline after 24 hours use.It was reported that the ventilator alarmed and the circuits were replaced.The three complaint rt266 breathing circuits will not be returned by the hospital facility for evaluation.No patient consequence was reported.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• 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: 5351857
• MDR Text Key: 35295912
• Report Number: 9611451-2016-00005
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT266
• Device Catalogue Number: RT266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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