MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-04-25 for DORNIER MEDILAS E NA manufactured by Dornier Medtech Systems Gmbh.
[17439383]
The power supply of the eryag-laser went with a large bang and caught fire. Evacuation of the operating room was necessary and response by the fire brigade. No injuries involved in the incidence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611388-2002-00002 |
| MDR Report Key | 390730 |
| Report Source | 05,06 |
| Date Received | 2002-04-25 |
| Date of Report | 2002-04-23 |
| Date of Event | 2002-03-28 |
| Report Date | 2002-04-23 |
| Date Mfgr Received | 2002-04-08 |
| Device Manufacturer Date | 1998-01-01 |
| Date Added to Maude | 2002-05-01 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. WOLFGANG HEPP |
| Manufacturer Street | ARGELSRIEDER FELD 7 |
| Manufacturer City | WESSLING D-82234 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-82234 |
| Manufacturer Phone | 8153888598 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORNIER MEDILAS E |
| Generic Name | ER YAG-LASER |
| Product Code | LXS |
| Date Received | 2002-04-25 |
| Model Number | MEDILAS E |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 379773 |
| Manufacturer | DORNIER MEDTECH SYSTEMS GMBH |
| Manufacturer Address | ARGELSRIEDER FELD 7 WESSLING GM D82234 |
| Baseline Brand Name | DORNIER MEDILAS E |
| Baseline Generic Name | ER YAG-LASER |
| Baseline Model No | MEDILAS E |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-04-25 |