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

Model Number	OPT844
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We are currently in the process of obtaining additional information from the customer regarding the opt844 optiflow adult nasal cannula.We will provide a follow-up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt844 optiflow adult nasal cannula was broken during patient use.There was no patient consequence.
Event or Problem Description
A healthcare facility in china reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt844 optiflow adult nasal cannula was broken during patient use.There was no patient consequence.
Additional Manufacturer Narrative
Ps356033 the opt844 interface is used to deliver humidified oxygen to patients.The opt844 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 that 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 opt844 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 on the product.Result: the customer reported that the tubing of an opt844 optiflow adult nasal cannula was broken.Conclusion: wiithout the complaint device, we are unable to determine the cause of the reported event.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 opt844 optiflow adult nasal cannula would have met the required specification at the time of production.The user instructions which accompany the opt844 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." "use only approved setup.".

• Brand Name: ADULT NASAL INTERFACE
• Common Device Name: CAT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 11052176
• Report Number: 9611451-2020-01214
• Device Sequence Number: 19094271
• Product Code: CAT
• UDI-Device Identifier: 09420012432124
• UDI-Public: (01)09420012432124(10)2101038252(11)200312
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2020

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: OPT844
• Device Catalogue Number: OPT844
• Device Lot Number: 2101038252
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 01/17/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1