MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-11-22 for CLEANSTATION CS20000 manufactured by Healthway Home Products, Inc.
[17886207]
Device is an advanced air purifier that caught fire while running. No injuries or property damage. Device was returned to mfr for eval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000634072-2011-00001 |
| MDR Report Key | 2363176 |
| Report Source | 04 |
| Date Received | 2011-11-22 |
| Date of Report | 2011-11-22 |
| Date of Event | 2011-09-24 |
| Date Mfgr Received | 2011-09-25 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2012-01-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 3420 MAPLE AVE |
| Manufacturer City | PULASKI NY 13142 |
| Manufacturer Country | US |
| Manufacturer Postal | 13142 |
| Manufacturer Phone | 3152982904 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEANSTATION |
| Generic Name | ADVANCED AIR PURIFICATION SYSTEM |
| Product Code | FRF |
| Date Received | 2011-11-22 |
| Returned To Mfg | 2011-09-26 |
| Model Number | CS20000 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEALTHWAY HOME PRODUCTS, INC |
| Manufacturer Address | PULASKI NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-22 |