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 2020-03-19 for VENTED AUTOFEED HUMIDIFICATION CHAMBER MR290V manufactured by Fisher & Paykel Healthcare Limited.
[187406574]
(b)(4). The three complaint mr290 vented autofeed humidification chambers were received at fisher & paykel healthcare (f&p) in (b)(4) but the evaluation has not yet begun. We will provide a follow up report upon completion of our investigation. Device 1: lot 191006. Device was received on 11 march 2020. Device 2 and device 3: lot 191017. Devices were received on 18 march 2020.
Patient Sequence No: 1, Text Type: N, H10
[187406575]
A healthcare facility in (b)(6) reported on behalf of a distributor, via a fisher & paykel healthcare (f&p) field representative, that three mr290 vented autofeed humidification chambers were leaking water from the bottom of the chamber domes. It was reported that a hole in the chamber plate of two mr290 devices was found. Nebulizer drug was used with aeroneb, along with meptin and bisorbin which were thinned with saline solution. There was no reported patient consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00293 |
| MDR Report Key | 9857604 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-16 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-19 |
| 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 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 | VENTED AUTOFEED HUMIDIFICATION CHAMBER |
| Generic Name | AUTOFEED CHAMBER |
| Product Code | BTT |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-11 |
| Model Number | MR290V |
| Catalog Number | MR290V |
| Lot Number | SEE H10 |
| 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 | 2020-03-19 |