MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-05-26 for VP2000 2J11-01 30-144101, 101, 102 manufactured by Abbott Molecular.
[20241419]
A new complaint has been received on an issue previously reported under report number 3005248192-0003. This new complaint entails a communication from a customer that reports that the vp2000 is overheating. (b) (4). This customer was not injured.
Patient Sequence No: 1, Text Type: D, B5
[20383287]
Abbott molecular has completed a root cause investigation of this vp2000 heating issue. (b) (4). The engineering group is considering several options to change the vp2000 hardware in order to correct this overheating issue. Please note that this issue has been previously reported under mdr 3005248192-2009-0003. Abbott molecular also conducted a recall, (b) (4), regarding this vp2000 heater and acknowledged receipt of the recall notice. Additional model #'s: -04, -60.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2009-00002 |
| MDR Report Key | 1446355 |
| Report Source | 07 |
| Date Received | 2009-05-26 |
| Date of Report | 2009-05-22 |
| Date of Event | 2009-04-27 |
| Date Mfgr Received | 2009-04-27 |
| Date Added to Maude | 2010-03-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAULA MARTIN, SENIOR MGR. |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617333 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VP2000 |
| Generic Name | VP2000 SLIDE SPECIMEN PROCESSOR |
| Product Code | KEY |
| Date Received | 2009-05-26 |
| Model Number | 2J11-01 |
| Catalog Number | 30-144101, 101, 102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR |
| Manufacturer Address | DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-26 |