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

Model Number	RT202
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt202 adult inspiratory heated breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the customer reported that the rt202 adult inspiratory heated breathing circuit was leaking air.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All breathing circuits are pressure tested for leaks during production and those that fail are rejected.The user instructions that accompany the rt202 adult inspiratory heated breathing circuit states the following: check all connections are tight before use.Perform a pressure and leak test on the breathing system and check for occlusions before connection to a patient.Ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.
Event or Problem Description
A distributor reported on behalf of the healthcare facility in (b)(6), via a fisher & paykel healthcare (f&p) field representative that a rt202 adult inspiratory heated breathing circuit was leaking air.There was no patient consequence.

• Brand Name: ADULT INSPIRATORY HEATED BREATHING CIRCUIT
• Common Device Name: BTT
• MDR Report Key: 12250742
• Report Number: 9611451-2021-00890
• Device Sequence Number: 14763556
• Product Code: BTT
• UDI-Device Identifier: 09420012430304
• UDI-Public: (01)09420012430304(10)2101458843(11)210112
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2021

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: RT202
• Device Catalogue Number: RT202
• Device Lot Number: 2101458843
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/29/2021
• 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