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

Model Number	RT219
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Codes	Viral Infection (2248); Insufficient Information (4580)
Date of Event	01/20/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).The complaint (b)(4) adult bi-level/cpap breathing circuit is expected, but has not yet returned to fisher & paykel healthcare (f&p) in (b)(6) for investigation to determine if our product caused or contributed to the reported event.
Event or Problem Description
A healthcare facility in (b)(6) reported that the (b)(4) adult bi-level/cpap breathing circuit disconnected from the bipap mask.The staff member then incorrectly reconnected the circuit to the filter instead of the mask.The patient has since passed away.We have requested further information from the healthcare facility to better understand the reported event.
Additional Manufacturer Narrative
(b)(4).Method: the complaint device was requested, however was not returned to fisher & paykel healthcare (f&p) for evaluation.Additional information with regards to the reported event and patient outcome was also requested from the hospital, however limited information was provided.Therefore, our investigation is based on the information provided by the customer and our knowledge of the product.Results: it was reported that the rt219 adult bi-level/cpap breathing circuit became unintentionally disconnected from the bipap mask.It was further reported that the circuit was reconnected to the filter instead of the bipap mask.It was reported that the patient was being treated for covid-19 and lhas since passed away.Conclusion: the reported reconnection of the circuit to the filter instead of the bipap mask was a result of user error.There was no reported damage or malfunction with the rt219 breathing circuit.The user instructions that accompany the rt219 bi-level/cpap breathing circuit include a pictorial showing the instructions to connect the circuit and exhalation port correctly.It also includes the following: check all connections are tight before use.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.Ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.Perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.For use under the supervision of trained medical personnel.
Event or Problem Description
A healthcare facility in wisconsin reported that the rt219 adult bi-level/cpap breathing circuit became unintentionally disconnected from the bipap mask.It was further reported that the circuit was reconnected to the filter instead of the bipap mask.The patient was in covid isolation and has since passed away.

• Brand Name: BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT
• Common Device Name: BTT
• MDR Report Key: 11639470
• Report Number: 9611451-2021-00375
• Device Sequence Number: 3157426
• Product Code: BTT
• UDI-Device Identifier: 09420012430311
• UDI-Public: (01)09420012430311(10)2100863667(11)190826
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K983112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: RT219
• Device Catalogue Number: RT219
• Device Lot Number: 2100863667
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEM FILTER; HEM FILTER; PHILLIPS V60 BIPAP MASK; PHILLIPS V60 BIPAP VENTILATOR; RESPIRONICS M AF541 MASK; RESPIRONICS M AF541 MASK; HEM FILTER; PHILLIPS V60 BIPAP MASK; RESPIRONICS M AF541 MASK
• Outcome Attributed to Adverse Event: Death