MAUDE Adverse Event Report: INFANT CONTINUOUS FLOW BREATHING CIRCUIT; BTT

Model Number RT132

Device Problems Infusion or Flow Problem (2964); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of finalizing our investigation.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 pressure line component of a rt132 infant continuous flow breathing circuit had an issue before use.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint rt132 infant continuous flow 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 the knowledge of our product.Results: the customer stated that the pressure line disconnected from the ventilator.The customer further reported that no visible damage was observed with the pressure line adaptor.Conclusion: without the complaint device.We are unable to determine what may have caused the reported failure.All rt132 infant continuous flow breathing circuits are visually inspected and pressure tested prior to being released for distribution, and those that fail are rejected.The subject rt132 infant continuous flow breathing circuit would have met the required specifications at the time of production.The user instructions that accompany the rt132 infant continuous flow breathing circuit states: check all connections are tight before use." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "set appropriate ventilator alarms.".

Event Description

A healthcare facility in france reported via a fisher & paykel healthcare (f&p) field representative that the pressure line component of a rt132 infant continuous flow breathing circuit had an issue before use.There was no patient involvement.

• Brand Name: INFANT CONTINUOUS FLOW BREATHING CIRCUIT
• Type of Device: BTT
• MDR Report Key: 10912719
• MDR Text Key: 219139878
• Report Number: 9611451-2020-01084
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K020332
• 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: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT132
• Device Catalogue Number: RT132
• Device Lot Number: 210075900
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• 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