MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-01-12 for VP 2000 PROCESSOR 02J11-001 manufactured by Abbott Molecular, Inc..
[21760241]
The abbott vp 2000 processor is a device designed to automate and standardize slide specimen processing and routine slide staining for the laboratory. Customer was running urovysion protocol and noticed that basin with the protease heated up to 69 degrees c when the program was set to 37 degrees c. Customer stopped the vp2000 instrument and rebooted. To troubleshoot the vp2000 customer filled the heated basins with water and started the instrument with the same protocol. The instrument heated unexpectedly and customer noticed smoke burning out of the heater module vp2000. Customer turned off the vp2000. Customer stated that the vp2000 heated basin temperatures were not being controlled properly, and that a small amount of smoke was observed near heater box #3. Field service noted that there was dried and crystallized reagent under heater box #1, and that this reagent had slowly advanced to the heater module assy. Control board ((b)(4)). Damage was observed on the heater module assembly, control board around the heater box power connectors, and it was determined that the crystallized reagent had "shorted" the heater box power connections. The circuit breaker (instrument on/off switch) was found in the "off" position, indicating that the circuit breaker tripped when the short occurred. Field service replaced the heater module assembly to resolve this issue. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005248192-2011-00001 |
| MDR Report Key | 2796736 |
| Report Source | 07 |
| Date Received | 2011-01-12 |
| Date of Report | 2011-01-12 |
| Date of Event | 2010-12-17 |
| Date Mfgr Received | 2010-12-17 |
| Date Added to Maude | 2012-11-01 |
| 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 | 0 |
| Remedial Action | RP |
| 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 | 2011-01-12 |
| Catalog Number | 02J11-001 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-01-12 |