MAUDE Adverse Event Report: INFANT VENTILATOR BREATHING CIRCUIT; BTT

Model Number	RT226
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint rt226 infant low flow breathing circuits was recently received at fisher & paykel healthcare (f&p) in (b)(6) for evaluation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in (b)(6) that a rt226 infant low flow breathing circuit had a hole in the and failed the ventilator leak test before use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt226 infant ventilator breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected.Results: visual inspection revealed a hole was found in the inspiratory limb.The hole was about 45 cm from the patient end connector.Conclusion: we are unable to determine the cause of the event.However, it is most likely that the hold on the inspiratory limb was due to a puncture by a sharp object.All rt226 infant ventilator breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The user instructions that accompany the rt226 also state the following: "do not stretch or milk the tubing"."visually inspect breathing sets for damaged (e.G.A crushed tube or cracked connector) before use and replace if damaged."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.".
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan that a rt226 infant ventilator breathing circuit had a hole in the and failed the ventilator leak test before use.There was no patient involvement.

• Brand Name: INFANT VENTILATOR BREATHING CIRCUIT
• Common Device Name: BTT
• MDR Report Key: 10912710
• Report Number: 9611451-2020-01086
• Device Sequence Number: 4295249
• Product Code: BTT
• UDI-Device Identifier: 09420012431165
• UDI-Public: 010942001243116510
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K020332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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: RT226
• Device Catalogue Number: RT226
• Device Lot Number: 2100980109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 01/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2020
• 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