MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-15 for ABBOTT VP 2000 PROCESSOR 02J11-01 manufactured by Abbott Molecular, Inc..
[123820528]
Complaint investigation is in process.
Patient Sequence No: 1, Text Type: N, H10
[123820549]
The abbott vp 2000 processor is a device designed to automate and standardize slide specimen processing including deparaffinization, fish pretreatment and routine slide staining for the laboratory. The unit is preprogrammed to perform slide pretreatment protocols for fish assays and can be programmed to perform routine histology/cytology slide staining or routine slide washing according to user requirements. Customer stated that they observed sparks before their vp2000 drying station stopped working. Molecular application specialist (mas) asked the customer to stop using the instrument until service was complete. Field service engineer (fse) arrived at the customer site and observed that the dryer station short circuited the electrical circuitry due to some liquid spill underneath the dryer assembly. The fse removed the dryer assembly in question and completed a clean up of the area underneath it. The new dryer assembly was installed, and the fse performed quality control test protocol on the instrument. The instrument passed and is working under manufacturing specification. No patient was involved. The observation was made by the vp2000 instrument user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005248192-2018-00014 |
| MDR Report Key | 7967049 |
| Date Received | 2018-10-15 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-09-14 |
| Date Mfgr Received | 2018-11-08 |
| Device Manufacturer Date | 2007-10-29 |
| Date Added to Maude | 2018-10-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOE HUTSON |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal | 600183315 |
| Manufacturer Phone | 2243617619 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600183315 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ABBOTT VP 2000 PROCESSOR |
| Generic Name | STAINER, TISSUE, AUTOMATED |
| Product Code | KEY |
| Date Received | 2018-10-15 |
| Catalog Number | 02J11-01 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 E. TOUHY AVE. DES PLAINES IL 600183315 US 600183315 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-15 |