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

Model Number RT319

Device Problem Obstruction of Flow (2423)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt319 adult bi-level cpap breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112.We are currently in the process of completing our investigation.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in the uk reported, via a fisher & paykel healthcare field representative, that the exhalation port of a rt319 adult bi-level cpap breathing circuit was found occluded by mucus build up during patient use.There was no reported patient consequence.

Event Description

A healthcare facility in the uk reported, via a fisher & paykel healthcare field representative, that the exhalation port of a rt319 adult bi-level cpap breathing circuit was found occluded by mucus build up during patient use.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).The rt319 adult bi-level cpap breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112.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 exhalation port of a rt319 adult bi-level cpap breathing circuit was found occluded by mucus build up during patient use.Conclusion: without the return of the complaint devices, we are unable to determine what may have caused the reported event.However based on the information provided, the fault was most likely due to mucus builds up in the exhalation port.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." "when using the exhalation port, it should not be used on patients who are nconscious, unable to breathe spontaneously, uncooperative or unresponsive." "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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 18127971
• MDR Text Key: 328165119
• Report Number: 9611451-2023-01062
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• 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
• Date Manufacturer Received: 12/07/2023
• 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
• Treatment: F&P MR850 RESPIRATORY HUMIDIFIER.; F&P MR850 RESPIRATORY HUMIDIFIER.; F&P RT017 EXHALATION PORT.; F&P RT017 EXHALATION PORT.; V60 VENTILATOR.; V60 VENTILATOR.