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 Tachycardia (2095)

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.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 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 hospital in (b)(6) reported via a fisher & paykel healthcare (f&p) representative that the rt319 adult bi-level cpap breathing circuit caused the ventilator to alarm due to secretions blocking the rt017 exhalation port.The patient experienced tachycardia (increased heart rate) and tachypnea (abnormally rapid breathing).The hospital further noted that no medical intervention was required and the patient fully recovered after the circuit was changed.

• 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: 8481230
• MDR Text Key: 141193416
• Report Number: 9611451-2019-00311
• 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: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• 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?: Yes
• Date Manufacturer Received: 03/05/2019
• 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