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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT; BZE
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FISHER & PAYKEL HEALTHCARE LTD INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT; BZE Back to Search Results
Model Number RT236
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/19/2014
Event Type  malfunction  
Event Description
A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) representative that the expiratory limb on an rt236 infant dual heated evaqua breathing circuit was pulled from the swivel wye and caused a leak.No patient consequence was reported.
 
Manufacturer Narrative
(b)(4).We are in the process of obtaining the complaint device for evaluation.We will provide a follow up report upon completion of our investigation.
 
Manufacturer Narrative
(b)(4).Method: only the expiratory limb of the complaint rt236 infant evaqua breathing circuit was returned to fisher & paykel healthcare in (b)(4) for evaluation.It was visually inspected and the expiratory heater wire was resistance tested using a calibrated multimeter.Results: visual inspection revealed a 40cm tear in the evaqua expiratory limb near the proximal connector.The resistance test showed that the expiratory heater wire was within specification.A lot check could not be carried out as the lot information was not provided.Conclusion: the damage observed on the returned evaqua expiratory limb indicates that it was most likely pulled at an angle.All rt236 breathing circuits are pressure tested for leak prior to distribution.Any breathing circuit which does not pass the pressure test is discarded.The subject rt236 infant breathing circuit would have met the required specification at the time of production.This suggests that the affected breathing circuit was damaged after it was released for distribution.The expiratory tube of evaqua circuits is composed of a thin, semi-permeable film specially designed to allow water vapor from expired ventilatory gases to pass through.This technology was developed to overcome condensate-related issues associated with conventional breathing circuits.The expiratory tube of an evaqua breathing circuit incorporates a protective mesh to prevent damage to the walls of the tube during use.Nonetheless, the evaqua tubing remains more susceptible to damage than conventional circuits when exposed to rough handling or to damage caused by blunt objects and circuit hangers.The user instructions that accompany the rt236 infant breathing circuit state the following: "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "use caution when positioning the circuit.Sharp or harsh edges and surfaces may damage the expiratory limb." "set appropriate ventilator alarms.".
 
Event Description
A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) representative that the expiratory limb on an rt236 infant dual heated evaqua breathing circuit was pulled from the swivel wye and caused a leak.No patient consequence was reported.
 
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Brand Name
INFANT DUAL-HEATED EVAQUA 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 Key4338882
MDR Text Key5138125
Report Number9611451-2014-00935
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K034026
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 11/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRT236
Device Catalogue NumberRT236
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received02/03/2015
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
Treatment
SERVO I VENTILATOR
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