MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT266

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device 1: lot#: 2102106298; date of manufacturing: 28-mar-2022; udi: (b)(4).Device 2: lot#: 2102119011; date of manufacturing: 03-apr-2022; udi: (b)(4).Device 3: lot#: 2101525365; date of manufacturing: 26-feb-2021; udi: (b)(4).Device 4: lot#: 2101618966; date of manufacturing: 05-may-2021; udi: (b)(4).Device 5: lot#: 2101695498; date of manufacturing: 02-jul-2021; udi: not provided.The complaint (b)(4) infant dual-heated evaqua2 breathing circuits are currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in new york reported, via a fisher & paykel healthcare (f&p) field representative, that the swivel of five rt266 infant dual-heated evaqua2 breathing circuits become detached prior patient use.There was no patient involvement.

Manufacturer Narrative

(b)(4).Corrected data: section d9 device available for evaluation? no.Section h3 device evaluated by manufacturer? other.Section d4 and h4: device 1: lot#: 2102106298; date of manufacturing: 28-mar-2022; udi: (b)(4).Device 2: lot#: 2102119011; date of manufacturing: 03-apr-2022; udi: (b)(4).Device 3: lot#: 2101525365; date of manufacturing: 26-feb-2021; udi: (b)(4).Device 4: lot#: 2101618966; date of manufacturing: 05-may-2021; udi: (b)(4).Device 5: lot#: 2101695498; date of manufacturing: 02-jul-2021; udi: not provided.Method: the complaint rt266 infant dual-heated evaqua2 breathing circuits were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the customer reported that the swivel of five rt266 infant dual-heated evaqua2 breathing circuits become detached prior patient use.Conclusion: without the complaint device, we are unable to determine what may have caused the reported event.All rt266 infant dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuits would have met the required specifications at the time of production.Our user instructions that accompany the rt266 infant dual-heated evaqua2 breathing circuit show in pictorial format the correct set-up of the circuit and also states 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.".

Event Description

A healthcare facility in new york reported, via a fisher & paykel healthcare (f&p) field representative, that the swivel of five rt266 infant dual-heated evaqua2 breathing circuits become detached prior patient use.There was no patient involvement.

• Brand Name: INFANT DUAL HEATED EVAQUA2 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 gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 15280440
• MDR Text Key: 305499159
• Report Number: 9611451-2022-00788
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT266
• Device Catalogue Number: RT266
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2022
• 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