• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FISHER & PAYKEL HEALTHCARE LTD BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT; BTT Back to Search Results
Model Number RT319
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/07/2015
Event Type  malfunction  
Event Description
A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) representative that an rt319 adult breathing circuit caused the heater wire disconnect alarm.No patient consequence was reported.
 
Manufacturer Narrative
(b)(4).The rt319 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 rt319 adult breathing circuit was returned to fisher & paykel healthcare for inspection.The returned circuit was visually inspected and inspiratory heater wire was resistance and continuity tested with a calibrated multimeter.Results: visual inspection revealed no damage to the returned circuit.The resistance test revealed that the inspiratory heater wire was out of specification.Continuity testing showed that the open circuit in the inspiratory heater wire was located between the heater wire and the left heater wire pin inside the overmoulded plug.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 rt319 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.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT
Type of Device
BTT
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ  2013
Manufacturer (Section G)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ   2013
Manufacturer Contact
raymond yan
15365 barranca parkway
irvine, CA 92618-2216
9494534000
MDR Report Key4489001
MDR Text Key20724904
Report Number9611451-2015-00063
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 01/08/2015
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 NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2015
Initial Date Manufacturer Received 01/08/2015
Initial Date FDA Received02/05/2015
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
Treatment
VENTILATOR OPT
-
-