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 2020-03-04 for ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT RT380 manufactured by Fisher & Paykel Healthcare Limited.
[187412992]
(b)(4). Two complaint rt380 adult dual heated evaqua2 breathing circuits were received at fisher & paykel healthcare (f&p) (b)(4) for evaluation to determine if f&p's products caused or contributed to the reported event. Evaluation is anticipated but not yet begun. We will provide a follow up report upon completion of our investigation.
Patient Sequence No: 1, Text Type: N, H10
[187412993]
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that two rt380 adult dual heated evaqua2 breathing circuits were damaged and leaking gas during use. It was reported that the leak test was not performed prior to use. There were no reported patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00239 |
| MDR Report Key | 9784577 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-04 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-03-04 |
| 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 DR. 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 | ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT |
| Generic Name | BZE |
| Product Code | BZE |
| Date Received | 2020-03-04 |
| Returned To Mfg | 2020-02-28 |
| Model Number | RT380 |
| Catalog Number | RT380 |
| Lot Number | 1509240301, NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-04 |