MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT BIAS FLOW BREATHING CIRCUIT; BZE

Model Number RT225

Device Problems Crack (1135); Material Split, Cut or Torn (4008)

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

Event Date 08/01/2022

Event Type  malfunction  

Event Description

A distributor reported on behalf of a healthcare facility in china, via a fisher & paykel healthcare (f&p) field representative, that the inspiratory limb of an rt225 infant ventilator circuit was found cracked.There was no patient involvement.

Manufacturer Narrative

(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Method: the complaint (b)(4) infant bias flow breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected.Results: visual inspection revealed a cut in the inspiratory limb of the subject circuit.It was also noted that the (b)(4) packaging bag was found cut open.Conclusion: we were unable to determine what may have caused the reported event.However, the inspiratory limb appeared to be cut with a sharp object.All (b)(4) infant bias flow breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the (b)(4) 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."."ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient."."visually inspect breathing sets for damage before use and replace if damaged.".

Event Description

A distributor reported on behalf of a healthcare facility in china, via a fisher & paykel healthcare (f&p) field representative, that the inspiratory limb of an rt225 infant bias flow breathing circuit was found cracked.There was no patient involvement.

• Brand Name: INFANT BIAS FLOW BREATHING CIRCUIT
• Type of Device: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomaroonni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 15189369
• MDR Text Key: 297796617
• Report Number: 9611451-2022-00728
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012431080
• UDI-Public: (01)09420012431080(10)2101787040(11)210903
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

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
• Device Operator: Health Professional
• Device Model Number: RT225
• Device Catalogue Number: RT225
• Device Lot Number: 2101787040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 10/06/2022
• Supplement Dates FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2021
• 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