MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT NASAL INTERFACE; BTT

Model Number	OPT946
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	07/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We are currently attempting to retrieve further information regarding the reported event.We will provide a follow up report upon completion of investigation.
Event or Problem Description
A healthcare facility in (b)(6) reported that an opt946 optiflow + adult nasal cannula had torn.The patient's oxygen saturation decreased to 84% spo2 and improved once the opt946 optiflow + adult nasal cannula was replaced.No further patient consequences was reported.
Event or Problem Description
A healthcare facility in massachusetts reported that an opt946 optiflow + adult nasal cannula had torn.The patient's oxygen saturation decreased to 84% spo2 and improved once the opt946 optiflow + adult nasal cannula was replaced.No further patient consequences was reported.
Additional Manufacturer Narrative
(b)(4).The opt946 optiflow + adult nasal cannula is an interface used to deliver humidified oxygen to patients and consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and features a head strap clip which works in tandem with the tubing clip (attaches to the patient's clothing/bedding) to support the weight of the circuit and prevent the cannula being dislodged.Method: the complaint opt946 optiflow + adult nasal cannula was not returned to fisher & paykel healthcare (f&p) for investigation.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the customer reported that the tubing of an opt946 optiflow + adult nasal cannula had torn.Conclusion: without the complaint device, we are unable to determine the cause of the reported damage.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 rejected.The subject opt946 optiflow + adult nasal cannula would have met the required specification at the time of production.The user instructions which accompany the opt946 optiflow + adult nasal cannula 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, to prevent loss of therapy." - "failure to use the set-up described above can compromise performance and affect patient safety.".

• Brand Name: ADULT NASAL INTERFACE
• Common Device Name: 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: 12517129
• Report Number: 9611451-2021-01081
• Device Sequence Number: 5169368
• Product Code: BTT
• UDI-Device Identifier: 09420012429742
• UDI-Public: (01)09420012429742(10)2101572167(11)210328
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K162553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OPT946
• Device Catalogue Number: OPT946
• Device Lot Number: 2101572167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 12/19/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 01/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Race: White