MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-10-02 for ELAN VESMATIC 20 * manufactured by *.
[217086]
This year the co contacted elan regarding the vesmatic interface with the sunquest lis system. Elan performed software updates that needed to be reconfigured in sunquest. Elan was not able to provide the needed documentation that described the software changes. The co learned that in fact elan performed multiple software changes without notifying customers and providing the needed documentation. Sunquest refused to update the instrument interface, and now the co can no longer auto transmit sed rate results. Elan was negligent in not making its customers aware of the software changes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1022986 |
| MDR Report Key | 354509 |
| Date Received | 2001-10-02 |
| Date of Report | 2001-10-02 |
| Date of Event | 2001-10-02 |
| Date Added to Maude | 2001-10-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELAN VESMATIC 20 |
| Generic Name | AUTOMATED SED RATE ANALYZER |
| Product Code | GKB |
| Date Received | 2001-10-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 343729 |
| Manufacturer | * |
| Manufacturer Address | 2 THURBER BLVD SMITHFIELD RI 02917 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-10-02 |