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

Model Number	OPT844
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of investigation.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in (b)(6), that the connector hook of the opt844 optiflow adult nasal cannula was found damaged before patient use.There was no patient involvement.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china, that the connector hook of the opt844 optiflow adult nasal cannula was found damaged before patient use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).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 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 opt844 nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photograph provided by the customer, and our knowledge of the product.Result: visual inspection of the provided photograph revealed that the interface was found broken from the left side.Conclusion: we are unable to determine the cause of the reported damage to the subject opt844 nasal cannula.However, the damage observed was likely due to overtightening or pulling of the headstrap.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 specification at the time of production.The setup instructions in the user instructions which accompany the opt844 nasal cannula include the following steps: "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: "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
• 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 ; 9494534002
• MDR Report Key: 13082567
• Report Number: 9611451-2021-01506
• Device Sequence Number: 14669304
• Product Code: CAT
• UDI-Device Identifier: 09420012432124
• UDI-Public: (01)09420012432124(10)2101543606(11)210308
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2021

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: OPT844
• Device Catalogue Number: OPT844
• Device Lot Number: 2101543606
• 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: 12/10/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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