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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED ADULT INSPIRATORY HEATED BREATHING CIRCUIT; BTT
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FISHER & PAYKEL HEALTHCARE LIMITED ADULT INSPIRATORY HEATED BREATHING CIRCUIT; BTT Back to Search Results
Model Number RT106
Device Problem Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2023
Event Type  malfunction  
Event Description
A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative, that the water trap of a rt106 adult breathing circuit was found leaking air prior to patient use.There was no patient involvement.
 
Manufacturer Narrative
(b)(4).The rt106 adult breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112.The complaint rt106 adult breathing circuit is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.
 
Manufacturer Narrative
(b)(4).The rt106 adult breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112.Method: the complaint rt106 adult breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand, where it was visually inspected and leak tested.Results: visual inspection of the complaint rt106 adult breathing circuit revealed no damage was found to any of the breathing circuit.The leakage test also revealed that the breathing circuit was within specification.Conclusion: we were unable to determine what may have caused the leakage as reported by the customer, as no fault was found with the returned device.All rt106 adult breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject infant breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt106 adult breathing circuit state the following: "check all connections are tight before use."."perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient."."ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".
 
Event Description
A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative, that the water trap of a rt106 adult breathing circuit was found leaking air prior to patient use.There was no patient involvement.
 
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Brand Name
ADULT INSPIRATORY HEATED BREATHING CIRCUIT
Type of Device
BTT
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LIMITED
15 maurice paykel place
east tamaki
auckland, 2013
NZ  2013
Manufacturer (Section G)
FISHER & PAYKEL HEALTHCARE LIMITED
15 maurice paykel place
east tamaki
auckland, 2013
NZ   2013
Manufacturer Contact
faranak gomarooni
17400 laguna canyon road
suite 300
irvine, CA 92618
9494534000
MDR Report Key16883926
MDR Text Key314720186
Report Number9611451-2023-00421
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012430564
UDI-Public(01)09420012430564(10)2101823483(11)210929(17)260929
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
SEE H10
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 04/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRT106
Device Catalogue NumberRT106
Device Lot Number2101823483
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received07/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2021
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
F&P MR850 RESPIRATORY HUMIDIFIER; F&P MR850 RESPIRATORY HUMIDIFIER
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