MAUDE Adverse Event Report: ADULT DUAL HEATED BREATHING CIRCUIT; BTT

Model Number	RT200
Health Effect - Clinical Codes	Dyspnea (1816); Low Oxygen Saturation (2477)
Date of Event	10/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We are in the process to determine whether f&p's product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative, that while using a rt200 adult dual heated breathing circuit, the ventilator alarmed for blockage.Subsequently, the patient experienced a shortness of breath and blood oxygen saturation decreased to 90% spo2.The patient was immediately provided auxiliary ventilation and the rt200 adult dual heated breathing circuit was replaced.The patient recovered to stable condition.
Event or Problem Description
A healthcare facility in china reported via a fisher & paykel healthcare (f&p) field representative, that while using a rt200 adult dual heated breathing circuit, the ventilator alarmed for blockage.Subsequently, the patient experienced a shortness of breath and blood oxygen saturation decreased to 90% spo2.The patient was immediately provided auxiliary ventilation and the rt200 adult dual heated breathing circuit was replaced.The patient recovered to stable condition.
Additional Manufacturer Narrative
(b)(4).Method: the complaint: rt200 breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.F&p field representative contacted the hospital to retrieve further information regarding the incident however, no further information was made available.Our investigation is based on the information event reported by the customer and our knowledge of the product.Conclusion: the customer stated that while using a rt200 adult dual heated breathing circuit, the ventilator alarmed for blockage.Without the complaint device, we are unable to confirm the reported fault.All rt200 adult dual-heated breathing circuits are tested during production and those that fail are rejected.The user instructions that accompany the rt200 state: "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".

• Brand Name: ADULT DUAL HEATED BREATHING CIRCUIT
• Common Device Name: BTT
• MDR Report Key: 10947095
• Report Number: 9611451-2020-01093
• Device Sequence Number: 14523735
• Product Code: BTT
• UDI-Device Identifier: 09420012430410
• UDI-Public: (01)09420012430410(10)2101067334(11)200405
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: SEE H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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
• Operator of Device: Health Professional
• Device Model Number: RT200
• Device Catalogue Number: RT200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 12/20/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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