MAUDE Adverse Event Report: BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT; BTT

Model Number RT319

Device Problems Complete Blockage (1094); Obstruction of Flow (2423)

Patient Problems Respiratory Distress (2045); No Known Impact Or Consequence To Patient (2692)

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 attempting to obtain further information from the customer to determine if our product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that the rt319 adult bi-level cpap breathing circuit caused respiratory distress on a tracheostomy patient due to secretions blocking the rt017 exhalation port.There was no reported patient consequences.

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.The complaint rt017 exhalation port and associated rt319 adult bi-level/cpap inspiratory-heated breathing circuit were not available to be returned to fisher & paykel healthcare for evaluation.Our investigation is thus based on the information provided by the hospital and our knowledge of the product.Without the return of the complaint devices, we are unable to determine if the devices had a malfunction which may have caused or contributed to the reported event.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.Any exhalation ports that fail this inspection are discarded.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 contraindications: when using the exhalation port, it should not be used on patients who: are unconscious, unable to breathe spontaneously, uncooperative or unresponsive.Have copious secretions, at risk of nausea/vomiting, or at risk of aspiration of emesis.If symptoms of these conditions occur discontinue treatment immediately the user instructions also states following warnings: check for occlusions in both inspiratory and pressure line before connecting to patient.Set appropriate ventilator alarms do not block or seal the vent holes on the exhalation port.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.

Event Description

A healthcare facility in the uk reported that the rt319 adult bi-level cpap breathing circuit caused respiratory distress on a tracheostomy patient due to secretions blocking the rt017 exhalation port.Further information was received that the patient experienced this type of event on several occasions.There was no reported patient consequences.

• Brand Name: BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT
• Type of Device: BTT
• MDR Report Key: 9736384
• MDR Text Key: 183961165
• Report Number: 9611451-2020-00188
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• 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: 2100619815
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• 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: PHILIPS V60 VENTILATOR; PHILIPS V60 VENTILATOR