MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-02-07 for ILO288 ECHOPORT LPT manufactured by Otodynamics, Ltd..
[2074588]
On (b)(6) 2007, otodynamics ltd was advised by (b)(4), its distributor in (b)(4), that a power supply unit attached to an otoacoustic emission analyser instrument [model ilo288 echoport with (b)(4)] had overheated and had emitted smoke sufficient to activate an automatic fire alarm system. Number of patients involved: none.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8021990-2008-00001 |
| MDR Report Key | 2143994 |
| Report Source | 99 |
| Date Received | 2008-02-07 |
| Date of Event | 2007-03-02 |
| Date Mfgr Received | 2007-03-06 |
| Date Added to Maude | 2011-07-07 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NONE |
| Product Code | EWO |
| Date Received | 2008-02-07 |
| Model Number | ILO288 ECHOPORT LPT |
| Catalog Number | ILO288 ECHOPORT LPT |
| Device Expiration Date | 2009-12-01 |
| Operator | OTHER |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTODYNAMICS, LTD. |
| Manufacturer Address | 26-38 BEACONSFIELD RD. HATFIELD AL108BB UK AL10 8BB |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-07 |