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 LIMITED INFANT 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 LIMITED INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE Back to Search Results
Model Number RT265
Device Problem Device Issue (2379)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complaint rt265 infant dual heated evaqua2 breathing circuit is currently en route to fph in (b)(4) for evaluation.We will provide 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 duckbill valve of an rt265 infant dual heated evaqua2 breathing circuit had disconnected and was found inside the y piece.The dislodged valve was found during the set up of the circuit.This was discovered before patient use.
 
Manufacturer Narrative
(b)(4).Method: the complaint rt265 infant dual heated evaqua2 breathing circuit was returned to fph in (b)(4) and was visually inspected.Result: visual inspection revealed that the duckbill valve was partly pushed into the swivel elbow.Conclusion: the complaint circuit was returned to fph in an unsealed package and we are thus unable to determine if the valve was dislodged during manufacturing or at the healthcare facility.All rt265 infant dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.A circuit with this damage would not have passed our testing.Our user instructions that accompany the rt265 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 duckbill valve of an rt265 infant dual heated evaqua2 breathing circuit had disconnected and was found inside the y piece.The dislodged valve was found during the set up of the circuit.This was discovered before patient use.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
Type of Device
BZE
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LIMITED
15 maurice paykel place
east tamaki
auckland, auckland 2013
NZ  2013
MDR Report Key7180565
MDR Text Key97376247
Report Number9611451-2018-00014
Device Sequence Number1
Product Code BZE
UDI-Device Identifier09420012430205
UDI-Public0109420012430205100718
Combination Product (y/n)N
PMA/PMN Number
K103767
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRT265
Device Catalogue NumberRT265
Device Lot Number2100267949
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2018
Was the Report Sent to FDA? No
Date Manufacturer Received12/12/2017
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-