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

Model Number	OPT946
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The opt946 cannula is used to deliver humidified oxygen to patients.The opt946 consists of a lightweight delivery tube which is connected to a rigid plastic base and soft nasal prongs (nasal interface).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 nares.Method: the complaint opt946 optiflow adult nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: the customer reported that the opt946 optiflow adult nasal cannula nasal prongs disconnected from the manifold during patient use.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.The reported event was most likely a result of an incorrect set-up of the device by the customer.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 cannula would have met the required specification at the time of production.The user instructions which accompany the opt946 cannula show in pictorial format the correct placement and fitting of the cannula and 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." the user instructions also contain the following warnings/cautions: "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 (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the opt946 optiflow adult nasal cannula nasal prongs disconnected from the manifold during patient use.It was reported that there was an interruption to the patient's therapy.There were no further reported patient consequences.
Event or Problem Description
A distributor in australia reported via a fisher & paykel healthcare (f&p) field representative that the opt946 optiflow + adult nasal cannula nasal prongs disconnected from the manifold during patient use.It was reported that there was an interruption to the patient's therapy.There were no further reported patient consequences.
Additional Manufacturer Narrative
(b)(4).Section h10 updated as complaint device was received for evaluation.The opt946 cannula is used to deliver humidified oxygen to patients.The opt946 consists of a lightweight delivery tube which is connected to a rigid plastic base and soft nasal prongs (nasal interface).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 nares.Method: the complaint opt946 optiflow + adult nasal cannula was received at fisher & paykel healthcare (f&p) in new zealand where it was visually inspected.Results: visual inspection of the opt946 optiflow + adult nasal cannula revealed that the tube was found stretched and torn next to the manifold.It was noted that the cannula was attached to the manifold.Conclusion: the reported event was most likely caused by the tube of the opt946 cannula being pulled.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 cannula would have met the required specification at the time of production.The user instructions which accompany the opt946 cannula show in pictorial format the correct placement and fitting of the cannula and 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." the user instructions also contain the following warnings/cautions: "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: OPTIFLOW + ADULT NASAL CANNULA
• Common Device Name: CAT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 10582408
• Report Number: 9611451-2020-00815
• Device Sequence Number: 3110841
• Product Code: CAT
• UDI-Device Identifier: 09420012429155
• UDI-Public: 010942001242915510
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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: 2100601474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1