MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + ADULT NASAL CANNULA; BTT

Model Number	OPT944E
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of retrieving further information.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A distributor in (b)(4) reported via a fisher & paykel healthcare (f&p) field representative that an opt944 optiflow + adult nasal cannula was found damaged during use.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of retrieving further information.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A distributor in (b)(4) reported via a fisher & paykel healthcare (f&p) field representative that an opt944 optiflow + adult nasal cannula was found damaged during use.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).The opt944e 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).This allows the device to be light weight and durable.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 opt944e optiflow + adult nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photograph provided by the customer, and our knowledge of our product.Results: visual inspection of the provided photograph revealed that the tubing was found to be stretched and torn.Conclusion: without the return of the subject cannula, we are unable to determine the cause of the reported event.However, based on our knowledge of the product and parts of the tubing being stretched, the reported event is likely caused by the cannula being subjected to excessive force.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 opt944e optiflow + adult nasal cannula would have met the required specifications.The user instructions which accompany the opt944e optiflow + adult nasal cannula show in pictorial format the correct placement and fitting of the cannula, including ensuring the headstrap clip and the tubing clip are appropriately attached.The user instructions also warn: - "ensure head strap clip is attached, to prevent cannula from being pulled out of the nares." - "cannula can become unattached if not used with the head strap clip." - "attach tubing clip to clothing/bedding to prevent cannula from pulling off face." - "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.".
Event or Problem Description
A distributor in france reported via a fisher & paykel healthcare (f&p) field representative that an opt944e optiflow + adult nasal cannula was found damaged during use.There was no reported patient consequence.

• Brand Name: OPTIFLOW + ADULT NASAL CANNULA
• 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: 13269915
• Report Number: 9611451-2022-00063
• Device Sequence Number: 17424700
• Product Code: BTT
• UDI-Device Identifier: 09420012429735
• UDI-Public: (01)09420012429735(10)2101504361(11)210211
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2021

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: Lay User/Patient
• Device Model Number: OPT944E
• Device Catalogue Number: OPT944E
• Device Lot Number: 2101504361
• 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: 12/23/2021
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 01/17/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2021
• 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 Sex: Unknown