Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 OPTIFLOW JUNIOR INTERFACE; 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 OPTIFLOW JUNIOR INTERFACE; BTT Back to Search Results
Model Number OPT316
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Fisher & paykel healthcare are currently in the process of retrieving further information regarding this complaint.We will provide a follow up report upon the completion of our investigation.
 
Event Description
A distributor in colombia reported via a fisher & paykel healthcare (f&p) representative that the tubing of an opt316 optiflow junior nasal cannula was damaged.There was no reported patient involvement.
 
Manufacturer Narrative
Ps400502 the optiflow junior nasal cannula is designed specifically for the delicate anatomical features and flow requirements of neonatal and paediatric patients.It features adhesive pads (wigglepads) to maintain cannula stability on the patient's cheeks, soft-touch nasal prongs and breathable kink-proof and crush-resistant flexible tubing.Method: the complaint opt316 optiflow junior nasal cannula was not received at fisher & paykel healthcare (f&p) new zealand for evaluation.Our investigation is thus based on the information and photograph provided by the customer and our knowledge on the product.Result: visual inspection of the provided photograph revealed that the tubing of the subject opt316 was damaged next to the swivel grip joint.Conclusion: we are unable to determine the cause of the reported event.All optiflow junior cannula are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.In addition, samples are taken hourly from each run and pull tested to check glue joint strength at the cannula/tube joint, as well as the swivel grip joint.If there are any failures the entire batch is put aside for further investigation.The subject opt316 optiflow junior nasal cannula would have met the required specification at the time of production.The user instructions which accompany the opt316 optiflow junior nasal cannula show in pictorial format the correct placement and fitting of the cannula and also warn: - ensure that all connections are secure during use.Check cannula is undamaged and that the flow path is maintained.Under excessive load, the cannula may disconnect to prevent forces being transferred to the patient.- appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death.- do not stretch or crush tube.
 
Event Description
A distributor in colombia reported via a fisher & paykel healthcare (f&p) representative that the tubing of an opt316 optiflow junior nasal cannula was damaged.There was no reported patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OPTIFLOW JUNIOR INTERFACE
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
faranak gomarooni
17400 laguna canyon road,
suite 300
irvine, CA 92618
9494534002
MDR Report Key15117888
MDR Text Key297440293
Report Number9611451-2022-00689
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012432292
UDI-Public(01)09420012432292(10)2101384001(11)201112
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOPT316
Device Catalogue NumberOPT316
Device Lot Number2101384001
Was Device Available for Evaluation? Yes
Date Manufacturer Received09/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-