MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-11-11 for UNK 0260223 manufactured by Roche Diagnostics.
[19540740]
The reporter stated that someone was shocked by the power cord about one week ago.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2005-03530 |
| MDR Report Key | 645951 |
| Report Source | 06 |
| Date Received | 2005-11-11 |
| Date of Report | 2005-10-18 |
| Date of Event | 2005-10-11 |
| Date Mfgr Received | 2005-10-18 |
| Date Added to Maude | 2005-11-16 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | CHRISTOF LITTWITZ |
| Manufacturer Street | 9115 HAGUE ROAD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | A/C D/C POWER ADAPTER FOR GTS UNIT |
| Product Code | FFZ |
| Date Received | 2005-11-11 |
| Model Number | NA |
| Catalog Number | 0260223 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 635459 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE RD. INDIANAPOLIS IN 46250 US |
| Baseline Brand Name | UNK |
| Baseline Generic Name | A/C D/C POWER ADAPTER FOR GTS UNIT |
| Baseline Model No | NA |
| Baseline Catalog No | 0260223 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-11-11 |