MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-21 for ORTHO SUMMIT PROCESSOR 7003015 936480 manufactured by Hamilton Bonaduz Ag.
[15441077]
The ortho summit processor instrument reportedly processed a microvell plate with one row of microwells on the plate consistently reading low ods. No death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2005-50135 |
| MDR Report Key | 595232 |
| Date Received | 2005-04-21 |
| Date of Report | 2005-04-21 |
| Date of Event | 2005-03-23 |
| Date Added to Maude | 2005-04-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHO SUMMIT PROCESSOR |
| Generic Name | ELISA MICROWELL PLATE PROCESSOR |
| Product Code | JTL |
| Date Received | 2005-04-21 |
| Model Number | 7003015 |
| Catalog Number | 936480 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 585061 |
| Manufacturer | HAMILTON BONADUZ AG |
| Manufacturer Address | * BONADUZ SZ CH 7402 |
| 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 | 1. Other | 2005-04-21 |