MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-27 for INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT RT265 manufactured by Fisher & Paykel Healthcare Ltd.
[184113492]
(b)(4). Method: the complaint rt265 infant dual-heated evaqua2 breathing circuit was returned to fph in (b)(4) for investigation, where it was visually inspected and pressure tested. Results: visual inspection revealed no damage to the returned breathing circuit. The pressure test revealed that the subject breathing circuit did not pass the test and was leaking from the swivel duckbill. Conclusion: we were unable to determine what may have caused the reported failure mode at this stage. All rt265 infant dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected. The subject infant breathing circuit would have met the required specifications at the time of production. Our user instructions that accompany the rt265 infant dual heated evaqua2 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. "
Patient Sequence No: 1, Text Type: N, H10
[184113493]
A distributor reported on behalf of a healthcare facility in (b)(6) via a fisher & paykel healthcare (f&p) field representative that the rt265 infant dual-heated evaqua2 breathing circuit failed the leak test during set-up. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00202 |
| MDR Report Key | 9760572 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-27 |
| Date of Report | 2020-01-28 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-01-28 |
| Date Added to Maude | 2020-02-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. FARANAK GOMAROONI |
| Manufacturer Street | 173 TECHNOLOGY DRIVE SUITE 100 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494534000 |
| Manufacturer G1 | FISHER & PAYKEL HEALTHCARE LTD |
| Manufacturer Street | 15 MAURICE PAYKEL PLACE EAST TAMAKI |
| Manufacturer City | AUCKLAND, 2013 |
| Manufacturer Country | NZ |
| Manufacturer Postal Code | 2013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT |
| Generic Name | BZE |
| Product Code | BZE |
| Date Received | 2020-02-27 |
| Returned To Mfg | 2020-02-14 |
| Model Number | RT265 |
| Catalog Number | RT265 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE LTD |
| Manufacturer Address | 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |