ICON PREMO
Report
- Report Number
- 9611451-2024-00784
- Event Type
- Malfunction
- Date Received
- November 20, 2024
- Report Date
- October 22, 2024
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BZD
- UDI-DI
- 09420012425034
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
(B)(6). METHOD: THE COMPLAINT ICON CPAP HUMIDIFIER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE CUSTOMER REPORTED THAT THE POWER CORD HAD BEEN CRACKED WITH EXPOSED COPPER WIRES. CONCLUSION: WITHOUT THE COMPLAINT DEVICE, WE ARE UNABLE TO CONFIRM THE REPORTED EVENT. THE ICON AUTO 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/NZS3200.1. OUR USER INSTRUCTIONS THAT ACCOMPANY THE ICON CPAP HUMIDIFIER 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." ICONPBN IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K094040.
A DISTRIBUTOR IN CANADA, REPORTED THAT THE POWER CORD OF AN ICON CPAP HUMIDIFIER HAS CRACKED WITH EXPOSED COPPER WIRES. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2458772 | ICON PREMO | CPAP | BZD | FISHER & PAYKEL HEALTHCARE LTD | ICONPBN-HT | 2100270528 | 09420012425034 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |