• 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 Problems Material Puncture/Hole (1504); Gas/Air Leak (2946)
Patient Problem No Patient Involvement (2645)
Event Date 10/30/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Method: the complaint rt380 adult evaqua2 breathing circuit was returned to fisher & paykel healthcare (f&p) in (b)(4) for investigation, where it was pressure tested.Results: the pressure test confirms that the breathing circuit was out of specification.The test showed that there was leak through small holes in the inspiratory limb.Conclusion: we were unable to determine the cause of this fault.All rt380 adult evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject infant breathing circuits would have met the required specifications at the time of production.Our user instructions that accompany the rt380 adult 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
A distributor on behalf of a healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that an rt380 adult dual-heated evaqua2 breathing circuit failed a ventilator leak test before use.There was no patient involvement.
 
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 gamarooni
173 technology drive
suite 100
irvine, CA 92618
9494534000
MDR Report Key9441242
MDR Text Key179768096
Report Number9611451-2019-01185
Device Sequence Number1
Product Code BZE
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 company representative,distri
Reporter Occupation Other
Type of Report Initial
Report Date 11/12/2019
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 NumberRT380
Device Catalogue NumberRT380
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2019
Initial Date Manufacturer Received 11/12/2019
Initial Date FDA Received12/09/2019
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
-
-