MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-08 for INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT RT265 manufactured by Fisher & Paykel Healthcare Limited.
[182335892]
(b)(4). The complaint rt265 infant dual heated evaqua2 breathing circuits are currently en route to fisher & paykel healthcare in (b)(4) for evaluation to determine if it had a malfunction, which could have caused or contributed to the reported event. We will provide a follow-up report once we have completed our investigation.
Patient Sequence No: 1, Text Type: N, H10
[182335893]
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare field representative that the pressure line of an rt265 infant dual heated evaqua2 breathing circuit pops off during device set up. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00032 |
| MDR Report Key | 9567204 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-08 |
| Date of Report | 2019-12-10 |
| Date of Event | 2019-12-10 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-08-20 |
| Date Added to Maude | 2020-01-08 |
| 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 CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494534000 |
| Manufacturer G1 | FISHER & PAYKEL HEALTHCARE LIMITED |
| 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 | 2020-01-08 |
| Returned To Mfg | 2020-01-23 |
| Model Number | RT265 |
| Catalog Number | RT265 |
| Lot Number | 2100857984 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE LIMITED |
| Manufacturer Address | 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-08 |