MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION; BTT

Model Number	OPT970
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	10/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in china reported that the tubing of an opt970 optiflow + tracheostomy direct connection was found damaged during use.The healthcare facility also reported that the patient desaturated, the subject device was replaced and the patient recovered.No further patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.Product background: the opt970 optiflow + tracheostomy direct connection is a patient interface used for delivery of humidified respiratory gases directly into the patient's tracheostomy.The interface is held in place by 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 tracheostomy.Additionally, a tubing clip (attaches to the patient's clothing/bedding) is provided to support the weight of the circuit and prevent the tubing from being dislodged.
Event or Problem Description
A healthcare facility in china reported that the tubing of an opt970 optiflow + tracheostomy direct connection was found damaged during use.The healthcare facility also reported that the patient desaturated, the subject device was replaced and the patient recovered.No further patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Product background: the opt970 optiflow + tracheostomy direct connection is a patient interface used for delivery of humidified respiratory gases directly into the patient's tracheostomy.The interface is held in place by a lanyard to support the weight of the circuit and prevent the tubing being dislodged from the patient's tracheostomy.Method: the complaint opt970 optiflow + tracheostomy direct connection was not returned to fisher & paykel healthcare (f&p) for evaluation.Results: the customer reported that the tubing of the opt970 optiflow + tracheostomy direct connection was damaged.Conclusion: without the return of the subject device, further information of the reported damage or photos, 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 disposed of.The subject interface would have met the specification at the time of production.Our user instructions that accompany the opt970 optiflow + tracheostomy direct connection interface states: 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: OPT970 OPTIFLOW + TRACHEOSTOMY DIRECT CONNECTION
• 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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 15928314
• Report Number: 9611451-2022-01134
• Device Sequence Number: 4347832
• Product Code: BTT
• UDI-Device Identifier: 09420012436917
• UDI-Public: (01)09420012436917(10)2102004215(11)220128
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/11/2022

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: OPT970
• Device Catalogue Number: OPT970
• Device Lot Number: 2102004215
• 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: 11/11/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• 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