MAUDE Adverse Event Report: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT268

Device Problems Detachment of Device or Device Component (2907); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt268 infant dual-heated evaqua2 breathing circuit is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k103767.The complaint rt268 infant dual-heated evaqua2 breathing circuit was recently received at fisher & paykel healthcare (f&p) in (b)(4).We will submit a follow-up report upon completion of our investigation.

Event Description

A distributor in (b)(4) reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the pressure line of a rt268 infant evaqua2 breathing circuit could not be connected to the pressure port and came off.There was no patient involvement.

Manufacturer Narrative

(b)(4).The rt268 infant dual-heated evaqua2 breathing circuit is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k103767.Method: the pressure line of the rt268 infant dual-heated evaqua2 breathing circuit was received at fisher & paykel healthcare (f&p) in new zealand for evaluation and was visually inspected.Results: visual inspection of the complaint pressure line revealed a moulding defect on the elbow of pressure line.Conclusion: we were unable to determine what caused the moulding defect of the pressure line elbow.The user instructions that accompany the rt268 infant dual-heated evaqua2 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 distributor in japan reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the pressure line of a rt268 infant evaqua2 breathing circuit could not be connected to the pressure port and came off.There was no patient involvement.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 9776473
• MDR Text Key: 184840683
• Report Number: 9611451-2020-00226
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT268
• Device Catalogue Number: RT268
• Device Lot Number: 2100878912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Date Manufacturer Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2019
• 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