MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-12-10 for VP 2000 PROCESSOR 02J11-001 manufactured by Abbott Molecular, Inc..
[3093590]
The abbott vp 2000 processor is a device designed to automate and standardize slide specimen processing and routine slide staining for the laboratory. A computer unit is part of the device. Customer reported that when attempted to boot up system, the computer (pc model (b)(4)) failed to initialize. In addition, the customer observed smoke emanating from pack of computer and a burning smell. Customer immediately disconnected computer from electrical outlet. No injuries were sustained.
Patient Sequence No: 1, Text Type: D, B5
[10238093]
The computer unit is currently under eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2010-00010 |
| MDR Report Key | 2796697 |
| Report Source | 07 |
| Date Received | 2010-12-10 |
| Date of Report | 2010-12-15 |
| Date of Event | 2010-11-15 |
| Date Added to Maude | 2012-10-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR DIMITRIS DEMIRTZOGLOU |
| Manufacturer Street | 1300 E TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617975 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 E TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VP 2000 PROCESSOR |
| Generic Name | STAINER, TISSUE, AUTOMATED, PRODUCT CODE: KEY |
| Product Code | KEY |
| Date Received | 2010-12-10 |
| Returned To Mfg | 2010-11-23 |
| Catalog Number | 02J11-001 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 E TOUHY AVENUE DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-10 |