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 2020-02-13 for FLEXITRUNK INFANT NASAL TUBING BC191 manufactured by Fisher & Paykel Healthcare Ltd.
[183155450]
(b)(4). We are in the process of clarifying specific model number of the product from the customer. We are also attempting to obtain the complaint device for evaluation to determine if fisher & paykel healthcare's 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
[183155451]
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare representative that "the cpap masks and prongs become loose and fall out of the generator". There was no reported patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00146 |
| MDR Report Key | 9709847 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-13 |
| Date of Report | 2020-01-17 |
| Date Mfgr Received | 2020-01-17 |
| Date Added to Maude | 2020-02-13 |
| 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 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 | FLEXITRUNK INFANT NASAL TUBING |
| Generic Name | BZO |
| Product Code | BZO |
| Date Received | 2020-02-13 |
| Model Number | BC191 |
| Catalog Number | BC191 |
| Lot Number | SEE H10 |
| 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 | 2020-02-13 |