MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT TRACHE DIRECT INTERFACE; BZA

Model Number OPT970

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The opt970 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.We are currently in the process of following up with the hospital to retrieve further information and the complaint opt970 device.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (f&p) representative that the opt970 tracheostomy interface disconnected during use.The circuit had come off from the connector part of the opt970.We were further informed that patient was coughing intensely from time to time and it is possible that the opt970 broke as a result of the cough.The hospital informed our field representative that the patient was without humidification at the time of incident but no patient consequences were reported.

Event Description

A hospital in finland reported via a fisher & paykel healthcare (f&p) representative that the opt970 tracheostomy interface disconnected during use.The circuit had come off from the connector part of the opt970 and it was later confirmed that the 900pt551 heated breathing tube was also in use.We were further informed that patient was coughing intensely from time to time and it is possible that the opt970 broke as a result of the cough.The hospital informed our field representative that the patient was without humidification at the time of incident but no patient consequences were reported.

Manufacturer Narrative

(b)(4).Method: the complaint opt970 was not returned to fisher & paykel healthcare in new zealand.Our investigation is based on our knowledge of the product and information provided by the hospital.Results & conclusion: we were unable to determine the cause of the reported fault.The hospital stated the patient sometimes coughs violently or has seizures and it is possible that the disconnection occurred during these events.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discolouration and stretching or deformation.Any product that fails the visual inspection is disposed of.Additionally, the 900pt551 hbt forms a tight fit with the opt900 series interface and requires over 15 newtons of force in order to disconnect it from the interface.During manufacture, samples of the hbt connector are tested with the opt series cannulae to ensure that the required disconnection force is greater than 15 newtons.The user instructions which accompany the opt970 state to "connect to the humidification system.Make sure all connections are secure" and warn that "appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death.".

• Brand Name: ADULT TRACHE DIRECT INTERFACE
• Type of Device: BZA
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8067833
• MDR Text Key: 128198099
• Report Number: 9611451-2018-00971
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1