MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT; BTT

Model Number RT319

Device Problems Obstruction of Flow (2423); Connection Problem (2900)

Patient Problems Tachycardia (2095); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining further information about the reported event.We will provide a follow up report upon the completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that a patient using the rt319 adult bi-level/cpap inspiratory-heated breathing circuit, as part of a non-invasive ventilation (niv) system experienced a peri arrest on a patient following "plugging" of rt017 exhalation port.It was further reported that a filter was connected to the rt017 exhalation port.There was no further reported patient consequence.

Event Description

A healthcare facility in the united kingdom reported, via a fisher & paykel healthcare (f&p) field representative, that the rt319 adult bi-level/cpap inspiratory-heated breathing circuit, experienced 'plugging' over of the expiratory port.The circuit was used as part of a non-invasive ventilation (niv) system.It was further reported that a filter was connected to the rt017 exhalation port.The patient experienced a peri arrest and recovered to a stable condition.There was no further reported patient consequence.

Manufacturer Narrative

(b)(4) corrected data: b5.Describe event or problem: a healthcare facility in southampton reported, via a fisher & paykel healthcare (f&p) field representative, that the rt319 adult bi-level/cpap inspiratory-heated breathing circuit, experienced 'plugging' over of the expiratory port.The circuit was used as part of a non-invasive ventilation (niv) system.It was further reported that a filter was connected to the rt017 exhalation port.The patient experienced a peri arrest and recovered to a stable condition.Method: the complaint rt319 bi-level/cpap breathing circuit and rt017 exhalation port were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the customer reported that the rt319 adult bi-level/cpap inspiratory-heated breathing circuit, experienced 'plugging' over of the expiratory port.The circuit was used as part of a non-invasive ventilation (niv) system.It was further reported that a filter was connected to the rt017 exhalation port.The patient experienced a peri arrest and recovered to a stable condition.Conclusion: without the return of the complaint devices, we are unable to determine what may have caused the reported event.Furthermore, there was no reported damage or malfunction with the rt319 bi-level/cpap breathing circuit.A recurring pin gauge test and visual inspection is conducted on the rt017 exhalation port to ensure there are no occlusions in the exhalation holes prior to release for distribution.The subject rt017 exhalation port would have met the required specification at the time of production.The user instructions that accompany the rt319 adult bi-level/cpap inspiratory-heated breathing circuit include the following warnings: - when using the exhalation port, it should not be used on patients who have copious secretions, at risk of nausea/vomiting, or at high risk of aspiration of emesis.If symptoms of these conditions occur, discontinue treatment immediately.- check for occlusions in both inspiratory and pressure line before connecting to patient.- appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death.- do not block or seal the vent holes on the exhalation port.- ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.

• Brand Name: BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT
• Type of Device: 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 ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 13237472
• MDR Text Key: 285984516
• Report Number: 9611451-2022-00012
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT319
• Device Catalogue Number: RT319
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2020
• 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
• Treatment: F&P RT017 EXHALATION PORT; F&P RT017 EXHALATION PORT; V60 VENTILATOR; V60 VENTILATOR