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

Model Number RT219

Device Problems Disconnection (1171); Misconnection (1399)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of retrieving further information and the subject bi-level/cpap inspiratory heated circuit.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 the rt219 bi-level/cpap breathing circuit, as part of a non-invasive ventilation (niv) system, became disconnected from the mask.The patient's family member then incorrectly reconnected the circuit.It was further reported that the patient desaturated, the respiratory therapist instantly corrected the issue and the patient recovered to a stable condition.There were no further patient consequences.

Event Description

A healthcare facility in utah reported, via a fisher & paykel healthcare (f&p) field representative, that the rt219 bi-level/cpap breathing circuit, as part of a non-invasive ventilation (niv) system, became disconnected from the mask.The patient's family member then incorrectly reconnected the circuit.It was further reported that the patient desaturated, the respiratory therapist quickly corrected the issue and the patient recovered to a stable condition.There were no further patient consequences.

Manufacturer Narrative

(b)(4).Method: multiple requests were made to retrieve the complaint device and further information with regards to the reported event; however, the device and further information were not received by fisher & paykel healthcare (f&p).Therefore, our investigation is based on the information provided by the customer and our knowledge of the product.Results: the customer reported that the rt219 bi-level/cpap breathing circuit, as part of a non-invasive ventilation (niv) system, became disconnected from the mask.The patient's family member then incorrectly connected the mask to the exhalation port, instead of the mask end of the exhalation port adaptor.It was further reported that the patient desaturated, the respiratory therapist quickly corrected the issue and the patient recovered to a stable condition.Conclusion: the reported misconnection of the bipap mask to the exhalation port end of the rt017 exhalation port component was a result of user error.The customer has also stated that the incorrect reconnection was due to 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.

• Brand Name: BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT
• Type of Device: BTT
• MDR Report Key: 12064704
• MDR Text Key: 261216125
• Report Number: 9611451-2021-00723
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K983112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT219
• Device Catalogue Number: RT219
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2021
• 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
• Treatment: F&P RT017 EXHALATION PORT; F&P RT017 EXHALATION PORT