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

Model Number OPT944

Device Problem Device Issue (2379)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the complaint device was not returned to fisher & paykel healthcare (b)(4) for evaluation.The hospital had informed us that the heated breathing tube (hbt) used was an 900pt551 airspiral hbt.Following this complaint we approached the hospital for further information, it was reported that no damage to the cannula or the circuit was observed.We were further informed that the patient: had to be bagged and masked with 100% oxygen to maintain saturation and later intubated.Was very fidgety and may have disconnected interface himself.Was very sick and they were expecting to intubate him - disconnection from airvo 2 may have just resulted in intubation happening sooner.Conclusion: the customer reported no damage to the cannula or the circuit.Thus, this suggest that there was no fault with the complaint device.It is possible that the cannula or the heated breathing tube were accidentally pulled or the patient was trying to remove them.The 900pt551 hbt forms a tight fit with the opt800 and opt900 series cannulae and requires over 15 newtons of force in order to disconnect it from the cannula.The user instructions (ui) for the airvo 2 system specifically warn that the airvo2 "is not intended for life support" and that "appropriate patient monitoring must be used at all times".The ui also instructs the caregiver to "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." 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.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.The setup instructions in the user instructions which accompany the opt944 nasal cannulae also 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." our f&p representative has arranged to provide further training to the hospital in setup and fitting of the cannula.

Event Description

A hospital in the (b)(6) reported via a fisher & paykel healthcare (f&p) representative that an opt944 nasal cannula became detached from the 900pt551 heated breathing tube, causing the patient to desaturate.There was no further patient consequence.

• Brand Name: ADULT NASAL INTERFACE
• Type of Device: 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 ; 9194534000
• MDR Report Key: 7603827
• MDR Text Key: 111349720
• Report Number: 9611451-2018-00509
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT944
• Device Catalogue Number: OPT944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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