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 Respiratory Distress (2045)

Event Date 09/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The rt319 adult b-ilevel 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 rt319 adult bi-level cpap circuit is not expected to be returned to fisher & paykel healthcare for investigation, however we have sent further questions to the hospital to obtain further information with regards to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (f&p) representative that four events involving two tracheostomy patients had occurred involving the rt017 exhalation port of the rt319 adult bi-level/cpap inspiratory-heated breathing circuit reportedly becoming clogged.F&p made inquiries with the hospital to determine the nature of the reported event/s.In response to this, the hospital reported that on the (b)(6) 2018 a patient could not perform expiration, became unstable and was bagged by hand.F&p understands the exhalation port was described as being tight through secretions.F&p understands that the exhalation port was replaced and after two hours the hospital reported that a similar event occurred with the same patient.The hospital additionally reported that on the (b)(6) 2018 another patient experienced the same sequence of events as above.The hospital has confirmed that both patients are in a stable condition.

Manufacturer Narrative

(b)(4).The rt319 adult b-ilevel 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 four complaint rt017 exhalation ports and associated rt319 adult bi-level/cpap inspiratory-heated breathing circuits 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 events.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 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.· 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 germany reported via a fisher & paykel healthcare (f&p) representative that four events involving two tracheostomy patients had occurred involving the rt017 exhalation port of the rt319 adult bi-level/cpap inspiratory-heated breathing circuit reportedly becoming clogged.F&p made inquiries with the hospital to determine the nature of the reported event/s.In response to this, the hospital reported that on the (b)(6) 2018, a patient could not perform expiration and became unstable.F&p understands the exhalation port was described as being tight through secretions.F&p understands that the exhalation port was replaced and after two hours the hospital reported that a similar event occurred with the same patient.The hospital additionally reported that on the 24 september 2018 another patient experienced the same sequence of events as above.The hospital has confirmed that both patients are in a stable condition.

• 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
• MDR Report Key: 7998148
• MDR Text Key: 124791949
• Report Number: 9611451-2018-00909
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 10/23/2018
• Supplement Dates Manufacturer Received: 09/24/2018
• Supplement Dates FDA Received: 11/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention