MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-16 for VITERA MASK FULL FACE MEDIUM A MODEL VIT1MA manufactured by Fisher & Paykel Healthcare Ltd.
[182588796]
(b)(4). We are currently in the process of obtaining the complaint mask to f&p in (b)(4). We will provide a follow-up report upon completion of our investigation.
Patient Sequence No: 1, Text Type: N, H10
[182588797]
A healthcare facility in the (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that the exhalation valve of a vit1ma vitera full face mask broke off and went into the patient's mouth. The patient had no further consequence. The subject mask is no longer in use by the patient. It was confirmed that there was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00066 |
| MDR Report Key | 9599408 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-01-16 |
| Date of Report | 2019-12-20 |
| Date Mfgr Received | 2020-02-29 |
| Date Added to Maude | 2020-01-16 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. FARANAK GOMAROONI |
| Manufacturer Street | 173 TECHNOLOGY DRIVE SUITE 100 |
| Manufacturer City | IRVINE, CA CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 8007923912 |
| 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 | VITERA MASK FULL FACE MEDIUM A MODEL |
| Generic Name | BZD |
| Product Code | BZD |
| Date Received | 2020-01-16 |
| Returned To Mfg | 2020-01-31 |
| Model Number | VIT1MA |
| Catalog Number | VIT1MA |
| Lot Number | NOT PROVIDED |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-01-16 |