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

Model Number RT266

Device Problem Increase in Pressure (1491)

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

Event Date 07/27/2016

Event Type  malfunction  

Manufacturer Narrative

The complaint rt266 infant dual heated evaqua2 breathing circuit is expected but has not yet been delivered to fisher & paykel healthcare (fph) in (b)(4) for evaluation.We are in process to determine if fph's product had a malfunction which may have caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

It was reported via a fisher & paykel healthcare field representative that the adaptor of the rt266 infant dual heated evaqua2 breathing circuit contains a clear section which was not removed prior to use and was used as part of the patient setup with an expiratory filter.It was stated that a patient was receiving 8 cmh2o peep instead of the 5 cmh2o that the ventilator was set to deliver.No further patient consequence was reported.

Manufacturer Narrative

(b)(4).The ventilator adaptor consists of a white connector and a transparent tube.The adaptor consists of two parts that can be separated for use on ventilators of different types.Method: the complaint rt266 infant breathing circuit was not returned to fisher & paykel healthcare (fph) for investigation.Therefore, our investigation is based on the information provided by the customer and our knowledge of the product.Results: it was found that the customer used the ventilator adaptor to connect the breathing circuit to a filter without removing the transparent tube prior to use.Conclusion: the adaptor assembly used by the customer is intended to connect the breathing circuit to ventilators with barbed connections.If their particular ventilator setup requires a 22mm ventilator adaptor and does not require this tube, then it should be detached prior to use.All rt266 breathing circuits are pressure tested before leaving the production line and those that fail are discarded.The 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.".

Event Description

It was reported via a fisher & paykel healthcare field representative that the adaptor of the rt266 infant dual heated evaqua2 breathing circuit contains a clear section which was not removed prior to use and was used as part of the patient setup with an expiratory filter.It was stated that a patient was receiving 8 cmh2o peep instead of the 5 cmh2o that the ventilator was set to deliver.No further 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 ; 173 technology drive; suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 5905459
• MDR Text Key: 53291537
• Report Number: 9611451-2016-00484
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• 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: 07/27/2016
• 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