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 2020-01-16 for ICON SERIES CPAP ICONPBN-HT manufactured by Fisher & Paykel Healthcare Ltd.
[183156150]
(b)(4). Method: the complaint icon cpap was not returned to fisher & paykel healthcare (f&p) for evaluation. Our investigation is thus based on the information provided by the customer. Results: customer reported that the icon cpap has a damaged power cord with exposed wires. Conclusion: based on the information we are unable to determine what caused the reported failure. During initial assembly of the icon cpap, all power cords are visually inspected for damage. Once the assembly process is completed, all icon cpap devices are visually inspected again before release for distribution. This suggests the damage occured after it had been distributed. The icon cpap is designed to the electrical safety standards, ul60601-1 and as/nzs 3200. 1. The materials used in the thermoplastic components of the mains connector and the cases are flame retardant according to ul 60601-1 and as/nzs 3200. 1. Our user instructions that accompany the icon state the following: "only operate if the device, power cord and plug are dry and in good working order. " "do not operate the device, water chamber or breathing tube if it is dropped, damaged or not working as intended. "
Patient Sequence No: 1, Text Type: N, H10
[183156151]
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that an icon cpap humidifier had a damaged power cord with exposed wires. There was no reported patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00064 |
| MDR Report Key | 9595084 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-16 |
| Date of Report | 2019-12-17 |
| Date Mfgr Received | 2019-12-17 |
| Device Manufacturer Date | 2013-03-25 |
| 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 DR., 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 | ICON SERIES CPAP |
| Generic Name | BZD |
| Product Code | BZD |
| Date Received | 2020-01-16 |
| Model Number | ICONPBN-HT |
| Catalog Number | ICONPBN-HT |
| Lot Number | 130325 |
| Operator | LAY USER/PATIENT |
| 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 | 2020-01-16 |