MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT MASK INTERFACE ADAPTER; BZA

Model Number OPT980

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The opt980 interface is used to deliver humidified respiratory gases to patients.The interface is held in place by a head strap and also includes a lanyard which is placed around the patient's neck or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's interface.Method: the two complaint opt980 mask interface adapters were returned to fisher & paykel healthcare in (b)(4), where they were visually inspected.Results: device 1: visual inspection of the opt980 device revealed that the tubing was torn and stretched.The lanyard accompanying the device was in its original packaging.Device 2: visual inspection of the opt980 device revealed that the tubing was torn and stretched.The tubing was returned without the mask adapter.Conclusion: we were unable to confirm the exact cause of the reported fault.However, it was mostly likely that the disconnection occurred as a result of pulling force being exerted on the device by the user or the weight of the breathing circuit pulling at the tube.All optiflow interfaces are inspected during production for visual defects.Any product that fails the visual inspection is rejected.Our user instructions that accompany the opt980 mask interface adapter has a pictorial diagram showing the correct use of the lanyard and tube clip.It also states: 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 crush or stretch tube, to prevent loss of therapy.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) representative that the opt980 mask interface adapters were disconnected from the tube.It was later reported that this occured during use.There were no reported patient consequences.

• Brand Name: ADULT MASK INTERFACE ADAPTER
• Type of Device: BZA
• 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 ; 9194534000
• MDR Report Key: 9455576
• MDR Text Key: 179773603
• Report Number: 9611451-2018-01191
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT980
• Device Catalogue Number: OPT980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Date Manufacturer Received: 11/12/2019
• 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 Number: 1