MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-28 for LIVING AIR AIR PURIFIER XL-15 manufactured by Contech Enterprises.
[20237616]
Complainant purchased an air purifier to be used indoors for an individual with extreme respiratory problems. She complains that independent testing on the device showed it could easily far exceed the safe levels of ppb of ozone. She stated that fda has set a limit of 50 ppb for the ozone from electronic air cleaners and that she understands that the ozone levels are too high when a distinct ozone odor becomes apparent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000004 |
| MDR Report Key | 10513 |
| Date Received | 1993-08-28 |
| Date Added to Maude | 1993-12-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIVING AIR AIR PURIFIER |
| Product Code | FRA |
| Date Received | 1993-08-28 |
| Model Number | XL-15 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10513 |
| Manufacturer | CONTECH ENTERPRISES |
| Manufacturer Address | SOUDON MN * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1993-08-28 |