MAUDE Adverse Event Report: INFANT BIAS FLOW BREATHING CIRCUIT; BZE

Model Number RT225

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt225 infant bias flow breathing circuit was not returned to fisher & paykel healthcare (f&p) (b)(4) for evaluation.We are in process to obtain more information to determine if f&p's product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor reported on behalf of a healthcare facility in (b)(6) that an rt225 infant bias flow breathing circuit failed a ventilator leak test before use.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint rt225 infant bias flow breathing circuit was not returned to fisher & paykel healthcare for evaluation.Questions were asked to the customer.Our investigation is thus based on information provided by the customer and our knowledge of the product.Results: the customer further reported that the water feedset spike was still in the winder during the leak test.Conclusion: we are unable to determine what caused the reported event.However, it is most likely due to the feedset spike was still in the winder during the leak test.The feedset winder is designed to secure the feedset and spike during transport and storage.It is not designed to seal the spike.All rt225 infant bias flow breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject circuit would have met the required specification at the time of production.Our user instructions that accompany the rt225 infant bias flow breathing circuit state the following: "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 reported on behalf of a healthcare facility in china that an rt225 infant bias flow breathing circuit failed a ventilator leak test before use.There was no patient involvement.

• Brand Name: INFANT BIAS FLOW BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 9522019
• MDR Text Key: 181951347
• Report Number: 9611451-2019-01253
• Device Sequence Number: 1
• Product Code: BZE
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT225
• Device Catalogue Number: RT225
• Device Lot Number: 2100490734
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2018
• 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