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 2020-01-13 for ICON SERIES CPAP ICONPBN-HT manufactured by Fisher & Paykel Healthcare Ltd.
[182348730]
(b)(4). The complaint icon cpap is currently en route to fisher & paykel healthcare (f&p) for evaluation. We will provide a follow-up report upon completion of our investigation.
Patient Sequence No: 1, Text Type: N, H10
[182348731]
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that an icon cpap humidifier had a broken power cord. Upon additional information received from the customer on 18 december 2019, it was reported that the power cord had exposed wires. There was no reported patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00052 |
| MDR Report Key | 9584534 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-13 |
| Date of Report | 2019-12-05 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2014-03-06 |
| Date Added to Maude | 2020-01-13 |
| 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 DR., SUITE 100 |
| Manufacturer City | IRVINE, CA 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 | ICON SERIES CPAP |
| Generic Name | BZD |
| Product Code | BZD |
| Date Received | 2020-01-13 |
| Returned To Mfg | 2020-02-20 |
| Model Number | ICONPBN-HT |
| Catalog Number | ICONPBN-HT |
| Lot Number | 140306 |
| 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 | 2020-01-13 |