MAUDE Adverse Event Report: ADULT BREATHING CIRCUIT; BTT

Model Number RT202

Device Problem Disconnection (1171)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining further information from the customer to determine if our product caused or contributed to the reported event.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the rt202 adult inspiratory heated breathing circuit disconnected from the mr290 humidification chamber port during use.It was reported that the patient experienced desaturation.There was no further reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint rt202 adult inspiratory heated breathing circuit is not returned to fisher & paykel healthcare for evaluation.We were unable to obtain further information from the customer despite our several attempts.Our investigation is thus based on the initial information reported by the customer and our knowledge of the product.Results: the customer reported that the inspiratory limb disconnected from the chamber.Conclusion: without the complaint device, we were unable to determine conclusively the cause of the reported event.All rt202 adult inspiratory heated breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution.Any breathing circuit which fails any of these tests is discarded.If any faults are detected, the whole batch is placed on hold for investigation.The user instructions that accompany the rt202 breathing circuit state the following: check all connections are tight before use set appropriate ventilator alarms do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.

Event Description

A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative that the rt202 adult inspiratory heated breathing circuit discconected from the mr290 humidification chamber port during use.It was reported that the patient experienced desaturation.There was no further reported patient consequence.

• Brand Name: ADULT BREATHING CIRCUIT
• Type of Device: BTT
• MDR Report Key: 9760613
• MDR Text Key: 184424708
• Report Number: 9611451-2020-00205
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

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
• Device Operator: Health Professional
• Device Model Number: RT202
• Device Catalogue Number: RT202
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 03/08/2020
• Supplement Dates FDA Received: 04/07/2020
• 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