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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 Air Leak (1008); Failure of Device to Self-Test (2937)
Patient Problem No Patient Involvement (2645)
Event Date 03/02/2015
Event Type  malfunction  
Event Description
A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) representative that three rt266 infant dual heated evaqua2 breathing circuits failed the leak test on a servo i ventilator.They further reported that air was leaking from the dryline tubes on all three circuits.This was found prior to patient use.
 
Manufacturer Narrative
(b)(4).The complaint device was recently returned to fisher & paykel healthcare in (b)(4) for evaluation.Our investigation is currently in progress and we will provide a follow up report upon completion of our investigation.
 
Manufacturer Narrative
(b)(4).Method: three rt266 infant dual heated evaqua2 breathing circuits have been returned to fisher & paykel healthcare in (b)(4) for evaluation.They were visually inspected and subsequently submerged in a water bath to determine the location of the leak.Results: visual inspection revealed that all three tubes were damaged near the chamber end connector and a pin size hole was noted on the three tubes.Stress marks were also noted on the chamber end connector on two of the returned dryline tubes.The water bath test showed bubbles forming from the pin size hole.A lot check revealed no other complaints of this nature for lot 141212.Conclusion: we are unable to accurately determine what may have caused the damage observed on the returned dryline tube.The dryline tube is a supplied part and the supplier has informed us that the dryline tubes are visually inspected for pin holes during packaging.Additionally, fph perform a sample pressure and leak test of the dryline tubes received prior to assembling the circuit.The user instructions that accompany the rt266 state: "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient" "set appropriate ventilator alarms" the hospital correctly tested the circuits prior to patient use, which is in line with our user instructions.(b)(4).
 
Event Description
A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) representative that three rt266 infant dual heated evaqua2 breathing circuits failed the leak test on a servo i ventilator.They further reported that air was leaking from the dryline tubes on all three circuits.This was found prior to 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
raymond yan
15365 barranca parkway
irvine, CA 92618-2216
9194534000
MDR Report Key4650699
MDR Text Key5685222
Report Number9611451-2015-00185
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K034026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/03/2015
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
Device Lot Number141212
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/26/2015
Initial Date FDA Received04/02/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/24/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SERVO I VENTILATOR; SERVO I VENTILATOR
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