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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED INFANT CONTINUOUS FLOW BREATHING CIRCUIT; BTT
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FISHER & PAYKEL HEALTHCARE LIMITED INFANT CONTINUOUS FLOW BREATHING CIRCUIT; BTT Back to Search Results
Model Number RT329
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complaint pressure relief valve of an rt329 infant continuous flow breathing circuit kit is not expected to be returned to fisher & paykel healthcare.We are currently in the process of obtaining further information from the hospital in order to assist us with the analysis and identification of a possible root cause of the reported event.We will provide a follow up report once we have completed our analysis.
 
Event Description
A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that the pressure relief valve of an rt329 infant continuous flow breathing circuit kit was damaged.This was observed before use on a patient.
 
Manufacturer Narrative
(b)(4).The complaint pressure relief valve of an rt329 infant continuous flow breathing circuit kit was not returned to fisher & paykel healthcare for investigation.Due to the nature of the subject pressure relief valve, there are possible failures that could manifest in the stated event description.Without the complaint device, we are unable to confirm the reported fault or determine its root cause.The rt329 infant continuous flow breathing circuit kit includes a pressure relief valve which ensures patient safety by limiting the pressure delivered in the event of an occlusion, as well as allowing connection to a pressure monitoring device or an oxygen analyzer.All pressure manifolds are pressure tested and visually inspected prior to distribution, and those that fail are rejected.This suggests that the subject pressure relief valve became damaged after it was released for distribution.Our user instructions that accompany the rt329 infant continuous flow breathing circuit state the following: "discard product if the pressure relief valve is damaged or damage is suspected."; "check that all connections, caps and/or plugs are tight before use."; "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient."; "patient monitoring is recommended."; "set appropriate ventilator alarms.".
 
Event Description
A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that the pressure relief valve of an rt329 infant continuous flow breathing circuit kit was damaged.This was observed before use on a patient.
 
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Brand Name
INFANT CONTINUOUS FLOW BREATHING CIRCUIT
Type of Device
BTT
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
173 technology dr., suite 100
irvine
9494534000
MDR Report Key5728212
MDR Text Key47496257
Report Number9611451-2016-00266
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K020332
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRT329
Device Catalogue NumberRT329
Device Lot Number140613
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/13/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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