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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW NASAL CANNULA INTERFACE CCK

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FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW NASAL CANNULA INTERFACE CCK Back to Search Results
Model Number AA031M
Device Problems Smoking (1585); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problem Superficial (First Degree) Burn (2685)
Event Date 03/09/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4). We are currently in the process of completing our investigation. We will provide a follow up report upon completion of investigation.
 
Event Description
A healthcare facility in australia reported via fisher & paykel healthcare (f&p) field representative that smoke was noticed whilst using the aa031m optiflow nasal cannula during monopolar diathermy, causing a singed eyebrow and a red forehead. The patient was provided soothing cream and was discharged as intended with no delay. No further patient consequence was reported. It was further reported that there was no malfunction with the device and the healthcare facility noted they used the aa031m optiflow nasal cannula incorrectly against the user instruction. The user instructions contain the following contraindication: "do not use this product with electrosurgery or electrocautery devices on the head or neck", contraindicating the use of the cannula during diathermy - a form of electrocautery.
 
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Brand NameOPTIFLOW NASAL CANNULA INTERFACE
Type of DeviceCCK
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
faranak gomarooni
173 technology drive
suite 100
irvine, CA 92618
9494534000
MDR Report Key14049256
MDR Text Key296749087
Report Number9611451-2022-00233
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
SEE H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberAA031M
Device Catalogue NumberAA031M
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/08/2022 Patient Sequence Number: 1
Treatment
F&P 950 RESPIRATORY HUMIDIFER; F&P 950 RESPIRATORY HUMIDIFER; F&P AA451 OPTIFLOW OXYGEN KIT; F&P AA451 OPTIFLOW OXYGEN KIT
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