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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE
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FISHER & PAYKEL HEALTHCARE LTD INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE Back to Search Results
Model Number RT266
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 07/06/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complaint rt266 infant dual-heated evaqua2 breathing circuits are currently en-route to fph (b)(4) for evaluation, to determine if they caused or contributed to the reported event.We will submit a follow-up report upon completion of our investigation.
 
Event Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that the swivel wye of three rt266 infant dual-heated evaqua2 breathing circuits were broken.This was discovered before patient use.
 
Manufacturer Narrative
(b)(4).Method: only one rt266 infant dual-heated evaqua2 breathing circuit was returned to fph in (b)(4) for evaluation.The returned infant breathing circuit was visually inspected and pressure tested.Results: visual inspection revealed a crack along one of the swivel wye ports.The pressure test result was outside specification.Conclusion: investigations into this issue have determined that the cracking has most likely occurred due to improperly mixed material in the batch.We have since contacted the supplier and arranged for them to supply the molding material with the two parts already mixed.We anticipate that this will resolve the issue and the project to implement this change is currently in process.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 infant breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt266 infant dual heated evaqua2 breathing circuits 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
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that the swivel wye of three rt266 infant dual-heated evaqua2 breathing circuits were broken.This was discovered before patient use.
 
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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
sharon kuruvilla
173 technology dr. suite 100
irvine, CA 92618
9494534000
MDR Report Key6762641
MDR Text Key81801040
Report Number9611451-2017-00700
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K103767
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/06/2017
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 NumberRT266
Device Catalogue NumberRT266
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/06/2017
Initial Date FDA Received08/02/2017
Supplement Dates Manufacturer Received07/06/2017
Supplement Dates FDA Received08/17/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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