MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2020-03-20 for NON-VENTED HOSPITAL FULL FACE MASK RT046 manufactured by Fisher & Paykel Healthcare Ltd.
[187410325]
(b)(4). We are currently in the process of investigation. We will provide a follow up report upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
[187410326]
A distributor reported on behalf of a heatlhcare facility in (b)(6) that the headgear strap of rt046 non-vented hospital full face masks were torn during use. There were no reported patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00299 |
| MDR Report Key | 9863021 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-20 |
| 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 TECHOLOGY DR. SUITE 100 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9194534000 |
| 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 | NON-VENTED HOSPITAL FULL FACE MASK |
| Generic Name | MNT |
| Product Code | MNT |
| Date Received | 2020-03-20 |
| Model Number | RT046 |
| Catalog Number | RT046 |
| Lot Number | NOT PROVIDED |
| 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 | 2020-03-20 |