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 2020-01-20 for ADULT VENTILATOR DUAL HEATED CIRCUIT KIT 950A81 manufactured by Fisher & Paykel Healthcare Ltd.
[182977718]
(b)(4). The 950a81 adult ventilator dual heated circuit kit 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. Method: the complaint 950a81 adult ventilator dual heated circuit kit was not received at fisher & paykel healthcare. Our investigation is thus based on the information provided by the customer and our knowledge of the product. Results: customer reported that a leak was observed to a component of the circuit. Conclusion: without the complaint device, we cannot conclusively determine the cause of the reported failure mode. All 950a81 adult ventilator dual heated breathing circuits are 100% leak tested during production, and those that fail are rejected. The subject 950a81 breathing circuit met the required specifications at the time of production. The user instructions which accompany the 950a81 adult ventilator dual heated circuit kit illustrate state the following: "perform a pressure and leak test on the breathing system before connecting to a patient. " "check all connections are tight before use. " the user instructions also warn the user: "set appropriate ventilator or flow source alarms to monitor therapy delivery. "
Patient Sequence No: 1, Text Type: N, H10
[182977719]
A healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that a leak was observed from a component of the 950a81 adult ventilator heated circuit kit. There was no reported patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00054 |
| MDR Report Key | 9608188 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-20 |
| Date of Report | 2019-09-23 |
| Date of Event | 2019-09-20 |
| Date Mfgr Received | 2019-09-23 |
| Date Added to Maude | 2020-01-20 |
| 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 | 2020-01-20 |
| Model Number | 950A81 |
| Catalog Number | 950A81 |
| Lot Number | 2100801718 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-01-20 |