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 2020-03-01 for INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT RT268 manufactured by Fisher & Paykel Healthcare Limited.
[184635936]
(b)(4). The rt268 infant dual-heated evaqua2 breathing circuit is not sold in the usa but it is similar to a product sold in the usa. The 510(k) for that product is k103767. The complaint rt268 infant dual-heated evaqua2 breathing circuit was recently received at fisher & paykel healthcare (f&p) in new zealand. We will submit a follow-up report upon completion of our investigation.
Patient Sequence No: 1, Text Type: N, H10
[184635937]
A distributor in (b)(6) reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the pressure line of two rt268 infant evaqua2 breathing circuits came off during setup. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00222 |
| MDR Report Key | 9772849 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-01 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2019-08-19 |
| Date Added to Maude | 2020-03-01 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 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 | 2020-03-01 |
| Returned To Mfg | 2020-02-28 |
| Model Number | RT268 |
| Catalog Number | RT268 |
| Lot Number | 2100856945 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-01 |