MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-16 for LUX GUARDIAN AIR F159B 0553 manufactured by Blueair.
[645503]
In 2007, customer returned the unit back to the franchise location alleges that he smelt it and saw the smoke, so unplugged it immediately. No property damage or bodily injury was reported by customer. That same day, the customer was given a new guardian air in exchange for the damaged unit. Customer agreed to the exchange and was satisfied. The following week, aerus' quality engineer received the damaged unit and performed a forensic analysis to determine the cause of failure. The engineer's conclusion reveals the fire occurred as the result of an internal failure of the pcb mounted power transformer. Why the transformer failed is yet to be determined. Investigation will continue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5001858 |
| MDR Report Key | 850837 |
| Date Received | 2007-05-10 |
| Date of Report | 2007-05-10 |
| Date of Event | 2007-05-01 |
| Date Added to Maude | 2007-05-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUX GUARDIAN AIR |
| Generic Name | GUARDIAN AIR |
| Product Code | FRF |
| Date Received | 2007-05-16 |
| Model Number | F159B |
| Catalog Number | 0553 |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 837892 |
| Manufacturer | BLUEAIR |
| Manufacturer Address | CHICAGO IL 60602 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-10 |