MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR INTERFACE; BTT

Model Number WJR112

Device Problems Loss of or Failure to Bond (1068); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of finalising our investigation for the complaint wjr112 optiflow junior interface.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that the wigglepads of the wjr112 optiflow junior interface were not sticking.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).The optiflow junior 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 wjr112 optiflow junior interface was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer, and our knowledge of the product.Results: the customer reported the wigglepads of the wjr112 optiflow junior interface were not sticking.Conclusion: without the complaint device we are unable to determine the cause of the reported event.The user instructions that accompany the optiflow junior cannula show in pictorial format how to correctly apply the cannula and also contain the following statement: "ensure infant's face is clean and dry." "check cannula remains secure on the face.Replace wigglepads if required.".

Event Description

A healthcare facility in denmark reported that the wigglepads of the wjr112 optiflow junior interface were not sticking.There was no reported patient involvement.

• 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 ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 13040506
• MDR Text Key: 284902573
• Report Number: 9611451-2021-01425
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WJR112
• Device Catalogue Number: WJR112
• Device Lot Number: 2101799072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1