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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED ADULT BI-LEVEL/CPAP INSPIRATORY-HEATED BREATHING CIRCUIT; BTT

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FISHER & PAYKEL HEALTHCARE LIMITED ADULT BI-LEVEL/CPAP INSPIRATORY-HEATED BREATHING CIRCUIT; BTT Back to Search Results
Model Number RT319
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 10/23/2014
Event Type  malfunction  
Event Description
A hospital in (b)(6) reported via a fisher & paykel field representative that the heaterwire of an rt319 adult bi-level/cpap inspiratory-heated breathing circuit caused a fisher & paykel healthcare mr850 respiratory humidifier to sound a disconnect alarm.This occurred prior to patient use.
 
Manufacturer Narrative
The rt319 adult bi-level/cpap inspiratory-heated breathing circuit that is referred to in the event description 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 rt319 breathing circuit was returned to fisher & paykel healthcare in (b)(4) for evaluation.A heaterwire resistance test was carried out using a calibrated multimeter.Results: the resistance test revealed that the inspiratory heater wire was out of specification.Continuity testing and visual inspection revealed that the open circuit in the inspiratory heater wire was located between the heater wire and the right heater wire pin inside the overmoulded plug.A lot check revealed one other complaint of this type for the lot number provided.Conclusion: we are unable to determine what may have caused the observed damage on the heater wire.Resistance tests and visual inspections are performed on all breathing circuits during production and circuits that fail are rejected.This suggests that the heater wire became open circuit after the product was released for distribution.The user instructions that accompany the breathing circuit state the following: - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "set appropriate ventilator alarms." hospital staff correctly checked the breathing circuit before patient use, which is in line with our user instructions.
 
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Brand Name
ADULT BI-LEVEL/CPAP INSPIRATORY-HEATED 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
15365 barranca parkway
irvine, CA 92618-2216
MDR Report Key4271905
MDR Text Key5029824
Report Number9611451-2014-00880
Device Sequence Number1
Product Code BTT
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
Reporter Occupation Other
Type of Report Initial
Report Date 11/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRT319
Device Catalogue NumberRT319
Device Lot Number140611
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2014
Initial Date Manufacturer Received 11/04/2014
Initial Date FDA Received11/23/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
FISHER & PAYKEL HEALTHCARE MR850 HUMIDIFIER
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