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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE
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FISHER & PAYKEL HEALTHCARE LIMITED INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE Back to Search Results
Model Number RT265
Device Problems Crack (1135); Material Discolored (1170)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that an rt265 infant dual heated evaqua2 breathing circuit was cracked.It was also reported that the breathing circuit was yellow in colour and very brittle around the discoloured area.This was observed before use on a patient.
 
Manufacturer Narrative
(b)(4).The complaint rt265 infant dual heated evaqua2 breathing circuit has only recently been returned to fisher & paykel healthcare in (b)(4) and is currently being investigated.We will provide a follow-up report once we have completed our investigation.
 
Manufacturer Narrative
(b)(4).Method: the evaqua expiratory limb of the complaint rt265 infant dual heated evaqua2 breathing circuit was returned to fph in (b)(4) and was visually inspected.Our analysis is also based on additional information provided by the hospital.Results: visual inspection of the returned evaqua expiratory limb revealed that the tube sustained two degraded sections, approximately 78mm and 910mm, from the heaterwire socket.The degraded sections were slightly yellow in colour and observed to be on the outer bend when the tube was coiled.It was also noted that the tube was brittle at the degraded sections.The hospital reported that they are storing the breathing circuits in a wire shelving unit prior to being placed on stand-by on the ventilators.The subject rt265 infant dual heated evaqua2 breathing circuit was stored in the wire shelving for approximately three to four days.It was also reported that the storage room had basic white tube lighting.A lot check was not performed as lot information was not provided.Conclusion: we were unable to determine definitively the root cause of the reported fault; however, it is possible that the basic tube lighting in the storage room had contributed the reported tube degradation.All infant evaqua breathing circuits are visually inspected and pressure tested during production, and those that fail are rejected.The subject rt265 infant evaqua infant breathing circuit would have met the required specification at the time of production.Our user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuit state the following: "this product is intended to be used for a maximum of 7 days." "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "reuse may result in transmission of infectious substances, interruption to treatment, serious harm or death." this is the only complaint of this nature that we received in the last 12 months to the end of july 2015 out of(b)(4) units sold worldwide for the same period.
 
Event Description
A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that an rt265 infant dual heated evaqua2 breathing circuit was cracked.It was also reported that the breathing circuit was yellow in colour and very brittle around the discoloured area.This was observed before use on a patient.
 
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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
Manufacturer (Section G)
FISHER & PAYKEL HEALTHCARE LIMITED
15 maurice paykel place
east tamaki
auckland, auckland 2013
NZ   2013
Manufacturer Contact
raymond yan
15365 barranca parkway
irvine
9494534000
MDR Report Key4858255
MDR Text Key5848477
Report Number9611451-2015-00225
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K103767
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative,company represent
Reporter Occupation Other
Type of Report Initial
Report Date 05/25/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2015
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 NumberNOT PROVIDED
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received05/25/2015
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
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