MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD TRACHEOSTOMY INTERFACE; BTT

Model Number OPT970

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The opt970 optiflow plus tracheostomy direct connection interface is used to deliver humidified oxygen to patients via tracheostomy.The interface is held in place by a neck 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 trache.Method: the complaint opt970 optiflow plus tracheostomy direct connection interface was not received at fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photograph provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Result: visual inspection of the provided photograph revealed that the tubing of an opt970e optiflow plus tracheostomy direct connection interface was detached from the swivel connector.The customer also noted that the patient tried to remove the cannula during use.Conclusion: based on the information provided, the reported damage was caused by the patient puling at the tube of the opt970e optiflow plus tracheostomy direct connection interface.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 plus 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.

Event Description

A healthcare facility in (b)(6) reported on behalf of a distributor, via a fisher & paykel healthcare (f&p) field representative, that the tubing of an opt970 optiflow plus tracheostomy direct connection interface was broken.The customer noted that the patient tried to remove the cannula during use.There was no reported patient consequence.

• Brand Name: TRACHEOSTOMY INTERFACE
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 11032425
• MDR Text Key: 222293417
• Report Number: 9611451-2020-01173
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012436917
• UDI-Public: (01)09420012436917(10)2101008994(11)200213
• Combination Product (y/n): N
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial
• Report Date: 11/20/2020

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
• Device Operator: Health Professional
• Device Model Number: OPT970
• Device Catalogue Number: OPT970
• Device Lot Number: 2101008994
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1