MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-11-09 for * manufactured by .
[7913423]
The instrument has been investigated. The field service engineer (fse) evaluated the instrument and found a burnt resistor on the dispense (disp) printed circuit board in the wash/dispense module. The board was replaced. The instrument was tested without further problem and returned to service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250051-2005-00528 |
| MDR Report Key | 787106 |
| Report Source | 05,06 |
| Date Received | 2005-11-09 |
| Date Mfgr Received | 2005-10-10 |
| Date Added to Maude | 2006-11-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LAURA VELLUCCI, PH.D |
| Manufacturer Street | 1001 US HWY 202 |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer Phone | 9082188532 |
| 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 | * |
| Product Code | JTL |
| Date Received | 2005-11-09 |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 774864 |
| Baseline Brand Name | ORTHO SUMMIT PROCESSOR |
| Baseline Generic Name | SAMPLE PROCESSOR |
| Baseline Model No | 7003015 |
| Baseline Catalog No | 936480 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-11-09 |