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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE
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FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE Back to Search Results
Model Number RT380
Device Problems Disconnection (1171); Leak/Splash (1354); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2022
Event Type  malfunction  
Event Description
A distributor reported on behalf of a healthcare facility in japan via a fisher & paykel healthcare (f&p) field representative, that the heater wire moulded plug of a rt380 adult dual heated evaqua2 breathing circuit disconnected prior patient use.There was no patient involvement.
 
Manufacturer Narrative
(b)(4).The complaint rt380 adult dual heated evaqua2 breathing circuit is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.
 
Manufacturer Narrative
(b)(4).Method: the complaint rt380 adult dual-heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand, where it was visually inspected.Results: visual inspection of the complaint rt380 adult dual-heated evaqua2 breathing circuit revealed that the inspiratory limb was returned with the heater wire moulded plug fully inserted and no damage was visible.The heater wire adaptor could be fully inserted without any problem.When pulling out the heater wire adaptor, the heater wire moulded plug pulled out of the inspiratory elbow.No damage was found to the pulled out heater wire moulded plug or elbow.Conclusion: we were unable to determine what may have caused the reported event at this time.All rt380 adult 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 specifications at the time of production.Our user instructions that accompany the rt380 adult 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." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." - "visually inspect breathing sets for damage before use and replace if damaged.".
 
Event Description
A distributor reported on behalf of a healthcare facility in japan via a fisher & paykel healthcare (f&p) field representative, that the heater wire moulded plug of a rt380 adult dual heated evaqua2 breathing circuit disconnected prior patient use.There was no patient involvement.
 
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Brand Name
ADULT 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
faranak gomarooni
17400 laguna canyon road
suite 300
irvine, CA 92618
9494534000
MDR Report Key15070823
MDR Text Key297231140
Report Number9611451-2022-00651
Device Sequence Number1
Product Code BZE
UDI-Device Identifier09420012429728
UDI-Public(01)09420012429728(10)2101744497(11)210803
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103767
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRT380
Device Catalogue NumberRT380
Device Lot Number2101744497
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received10/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2021
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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