MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-01-10 for ECHOSCREEN TEOAE HEARING SCREENER 010128 manufactured by Fischer-zoth Diagnosesysteme, Gmbh.
[604294]
During the charge cycle, the battery pack of the echoscreen teoae hearing screener caught on fire at hospital. The estimated charge time before the incident occurred in 2-3 hours. The battery charger was plugged into a wall outlet or power strip. There was a power surge protector from the power source being used. There were no power supply interruptions during the battery charging cycle. There was no liquid spilled in the area where the battery was being charged. There were no objects placed on top of the battery during the charging cycle. The battery was not exposed to mechanical shock, nor was it damaged mechanically. It did not fall to the floor. The indicator light was functioning properly (flashing slowly) during the charge cycle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2938854-2007-00001 |
| MDR Report Key | 811481 |
| Report Source | 05,06 |
| Date Received | 2007-01-10 |
| Date of Report | 2007-01-10 |
| Date of Event | 2006-12-06 |
| Date Mfgr Received | 2006-12-11 |
| Date Added to Maude | 2007-02-05 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LUANNE NG, MGR |
| Manufacturer Street | 1501 INDUSTRIAL RD |
| Manufacturer City | SAN CARLOS CA 94070 |
| Manufacturer Country | US |
| Manufacturer Postal | 94070 |
| Manufacturer Phone | 8002553901 |
| Manufacturer G1 | FISCHER-ZOTH DIAGOSESYSTEME, GMBH |
| Manufacturer Street | * |
| Manufacturer City | GERMERING |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECHOSCREEN TEOAE HEARING SCREENER |
| Generic Name | HEARING SCREENER |
| Product Code | EWO |
| Date Received | 2007-01-10 |
| Returned To Mfg | 2006-12-11 |
| Model Number | TEOAE |
| Catalog Number | 010128 |
| Lot Number | BATTERY - 050605 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 798967 |
| Manufacturer | FISCHER-ZOTH DIAGNOSESYSTEME, GMBH |
| Manufacturer Address | WALTER-KOLBENHOFF-STR 34 GERMERING GM |
| Baseline Brand Name | ECHOSCREEN TEROAE HEARING SCREENER |
| Baseline Generic Name | HEARING SCREENER |
| Baseline Model No | TEOAE |
| Baseline Catalog No | 010128 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-01-10 |