MAUDE Adverse Event Report: OPTIFLOW + MASK INTERFACE ADAPTER; BZA

Model Number OPT980E

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One of the complaint opt980 mask interface adapters is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor in (b)(4) reported, via a fisher & paykel healthcare (f&p) representative, that opt980 mask interface adapters were "coming apart at the base of the tubing" during use.There were no patient consequences.

Event Description

A distributor in canada reported, via a fisher & paykel healthcare (f&p) representative, that three opt980e optiflow + mask interface adapters were "coming apart at the base of the tubing" during use.There were no patient consequences.

Manufacturer Narrative

(b)(6) section d4 lot#: the lot number for one of the three complaint devices was provided and included in this report.The opt980e optiflow + mask interface adapter 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: one of the three complaint opt980e optiflow + mask interface adapters was returned to fisher & paykel healthcare (f&p) in new zealand, where it was visually inspected.Result: visual inspection of the returned opt980e optiflow + mask interface adapter revealed that the tubing was stretched and detached at the 3-way connector.The customer later reported that the provided lanyard of the interface was not used.Conclusion: we were unable to determine the cause of the reported fault.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discoloration and stretching or deformation.Any product that fails the visual inspection is disposed of.The subject interface would have met the specification at the time of production.The user instructions which accompany the opt980e optiflow + mask interface adapter show in pictorial format the correct placement and fitting of the cannula and also warn: - "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." - "do not soak, wash, sterilize, or reuse this product.".

• Brand Name: OPTIFLOW + MASK INTERFACE ADAPTER
• Type of Device: BZA
• MDR Report Key: 11240994
• MDR Text Key: 238888574
• Report Number: 9611451-2021-00102
• Device Sequence Number: 1
• Product Code: BZA
• UDI-Device Identifier: 09420012436948
• UDI-Public: (01)09420012436948(10)2101225661(11)200806
• Combination Product (y/n): N
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT980E
• Device Catalogue Number: OPT980
• Device Lot Number: 2101225661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Date Manufacturer Received: 03/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2020
• 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
• Treatment: F&P 900PT290E HUMIDIFICATION CHAMBER; F&P 900PT560 HEATED BREATHING TUBE; F&P PT101 AIRVO 2 HUMIDIFIER