MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-04-04 for VP 2000 PROCESSOR 02J11-004 manufactured by Abbott Molecular, Inc..
[2460552]
The abbott vp 2000 processor is a device designed to automate and standardize slide specimen processing and routine slide staining for the laboratory. A customer and a field service representative in (b)(4) alleged that the metal edges of an abbott vp 2000 processor (heater block, covers) unit are very sharp. The parts with edges that are allegedly sharp include the cover for the ambient temperature baths and when the heated basins are removed, the openings of the heater reagent basins. Drying station and water bath have allegedly sharp edges also. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[9572342]
Abbott molecular requested the return of the instrument with the alleged sharp edges for complaint investigation. The complaint is currently under investigation. Abbott molecular completed a sharpness test on a vp2000 instrument currently in use at abbot molecular. This instrument passed on all user accessible edges (per ul standard 1439).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2011-00002 |
| MDR Report Key | 2370401 |
| Report Source | 07 |
| Date Received | 2011-04-04 |
| Date of Report | 2011-04-04 |
| Date of Event | 2011-03-07 |
| Date Mfgr Received | 2011-03-07 |
| Date Added to Maude | 2012-03-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR DIMITRIS DEMIRTZOGLOU |
| Manufacturer Street | 1300 EAST 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 EAST 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 |
| Date Received | 2011-04-04 |
| Catalog Number | 02J11-004 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 EAST TOUHY AVENUE DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-04 |