Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE Back to Search Results
Model Number RT380
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/07/2022
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 expiratory limb of a rt380 adult dual heated evaqua2 breathing circuit was found damaged during patient use.There was no patient consequence.
 
Manufacturer Narrative
(b)(4).We are currently in the process of finalising our investigation.We will provide a follow up report upon completion of our investigation.
 
Event Description
A distributor reported on behalf of a healthcare facility in japan via a fisher & paykel healthcare (f&p) field representative that the expiratory limb of a rt380 adult dual heated evaqua2 breathing circuit was found damaged during patient use.There was no patient consequence.
 
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 and analysed.Results: visual inspection of the returned rt380 adult dual heated evaqua2 breathing circuit identified degradation to the expiratory limb.Further analysis revealed that the tube was exposed to chemicals.Conclusion: we are unable to determine the cause of the reported event.However, based on our investigation, it was most likely due to chemical exposure to the expiratory limb.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 evaqua2 breathing circuit show in pictorial format the correct set-up of the circuit and also states 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." - "do not soak, wash or sterilize this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 drive
suite 300
irvine, CA 92618
9494534000
MDR Report Key15189394
MDR Text Key297796247
Report Number9611451-2022-00718
Device Sequence Number1
Product Code BZE
UDI-Device Identifier09420012429728
UDI-Public(01)09420012429728(10)2101715706(11)210711
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K122432
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 07/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2022
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 Number2101715706
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received09/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-