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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE

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FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE Back to Search Results
Model Number RT340
Event Date 08/21/2012
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Method: the complaint breathing circuit was returned to the manufacturer for evaluation. The complaint breathing circuit was visually inspected and pressure tested for leaks. Results: the visual inspection revealed a hole in the expiratory (evaqua) limb, approximately 11cm away from the patient end connector. The pressure test confirmed the reported leak. A lot check could not be performed as no lot number was provided. Conclusion: based on inspection of the damage, it is likely that the evaqua expiratory limb was punctured or scratched by a blunt during use. The hospital has further reported that they used a drager circuit hanger. All rt340 breathing circuits are pressure tested for leaks prior to distribution and those that fail are rejected. This suggests that the breathing circuit was damaged post-production. The key difference between the evaqua breathing circuits and conventional breathing circuits is that the expiratory tube of evaqua circuits such as the rt340 is composed of a thin, semi-permeable film specially designed to allow water vapour from expired ventilatory gas to pass through. The evaqua expiratory tube has a protective mesh which prevents damage to the walls of the tube, however the evaqua tubing remains more susceptible to damage than conventional circuits when exposed to rough handling or damage caused by sharp objects and non-fph circuit hangers. The user instructions supplied with the rt340 breathing circuit state: perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient; set appropriate ventilator alarms; fit only the supplied fisher & paykel healthcare circuit hanger with care to avoid circuit damage.

 
Event Description

A hospital in (b)(6) reported that there was a leak in the expiratory limb of an rt340 adult dual-heated evaqua breathing circuit after 2 days of use causing the evita 4 ventilator to alarm. No patient consequence was reported.

 
Manufacturer Narrative

(b)(4). The complaint device has been returned to the manufacturer. Evaluation is anticipated and we are currently attempting to obtain further detailed information. We will provide a follow up report upon completion of our investigation.

 
Event Description

A hospital in (b)(6) reported that there was a leak in the expiratory limb of an rt340 adult dual-heated evaqua breathing circuit after 2 days of use causing the evita 4 ventilator to alarm. No patient consequence was reported.

 
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Brand NameADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT
Type of DeviceBZE
Manufacturer (Section F)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland,
NEW ZEALAND 2013
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland,
NEW ZEALAND 2013
Manufacturer (Section G)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland,
NEW ZEALAND 2013
Manufacturer Contact
raymond yan
15365 barranca parkway
irvine , CA 92618-2216
(949) 453 -4000
Device Event Key2782776
MDR Report Key2753562
Event Key2650157
Report Number9611451-2012-00658
Device Sequence Number1
Product CodeBZE
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 08/24/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/21/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberRT340
Device Catalogue NumberRT340
Device LOT NumberNP
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/10/2012
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received08/24/2012
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/21/2012 Patient Sequence Number: 1
Treatment
EVITA 4 VENTILATOR
EVITA 4 VENTILATOR
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