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

Model Number RT200

Device Problem Obstruction of Flow (2423)

Patient Problems Dyspnea (1816); Low Oxygen Saturation (2477)

Event Date 10/30/2020

Event Type  malfunction  

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 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 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.

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
• Type of Device: BTT
• MDR Report Key: 10947095
• MDR Text Key: 220239444
• Report Number: 9611451-2020-01093
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430410
• UDI-Public: (01)09420012430410(10)2101067334(11)200405
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT200
• Device Catalogue Number: RT200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• 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