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 2020-02-26 for ADULT VENTILATOR DUAL HEATED CIRCUIT KIT 950A81 manufactured by Fisher & Paykel Healthcare Ltd.
[184423167]
(b)(4). The 950a81 adult ventilator dual heated circuit is not sold in the usa but it is similar to a product which is sold in the usa. The 510(k) for that product is k122432. The complaint 950a81 adult ventilator dual heated circuits are currently en route to fisher & paykel healthcare (f&p) for evaluation to determine if our product caused or contributed to the reported event. We will provide a follow-up report upon completion of our investigation.
Patient Sequence No: 1, Text Type: N, H10
[184423168]
A healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that two 950a81 adult ventilator heated circuits failed the leak test prior to patient use. There was no reported patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00198 |
| MDR Report Key | 9759119 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-26 |
| Date of Report | 2020-01-29 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2019-06-20 |
| Date Added to Maude | 2020-02-26 |
| 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 SUITE 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 | ADULT VENTILATOR DUAL HEATED CIRCUIT KIT |
| Generic Name | BZE |
| Product Code | BZE |
| Date Received | 2020-02-26 |
| Model Number | 950A81 |
| Catalog Number | 950A81 |
| Lot Number | 2100801718 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-02-26 |