MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,07 report with the FDA on 2009-07-27 for VITEK SYSTEM VITEK 120, 220V W3202 manufactured by Biomerieux, Inc..
[20820540]
A biomerieux field service engineer (fse) was dispatched to the facility to determine whether there were any additional issues related to this event. The fse repaired the instrument by removing the old fuse and replacing it with a new one. The instrument performed as expected after the fuse had been replaced. The system was then checked to electrical equipment standard and was determined to be functioning properly with no electrical risk. The technical dept. From the reporting customer also checked the system to another standard and found no electrical risk. This event was the result of removing the fuse cover of the instrument.
Patient Sequence No: 1, Text Type: N, H10
[20838830]
Reporter reported that a customer had received an electrical shock from the their vitek reader. The customer had contacted their biomerieux field service representative via phone when they noticed that the run light on the vitek reader was not lit, but their system was powered on. The field service representative indicated that a qualified technician at the facility should check the instrument's fuses. However, it was reported that the customer who called in the issue attempted to check the fuse themselves. The customer removed the fuse cap and while trying to turn the instrument for easier access to the fuse, they touched the open fuse socket and received an electrical shock. The customer was hospitalized for half a day to perform heart rate monitoring. It has been reported that the customer is now doing fine and the hospital stay was a precautionary measure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2009-00001 |
| MDR Report Key | 1422924 |
| Report Source | 00,01,07 |
| Date Received | 2009-07-27 |
| Date of Report | 2009-07-24 |
| Date of Event | 2009-07-02 |
| Date Mfgr Received | 2009-07-02 |
| Device Manufacturer Date | 1991-01-01 |
| Date Added to Maude | 2009-07-31 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NATHAN HARDESTY, SR. SPEC. |
| Manufacturer Street | 595 ANGLUM RD. |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318666 |
| Single Use | 0 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITEK SYSTEM |
| Generic Name | VITEK INSTRUMENT |
| Product Code | LTW |
| Date Received | 2009-07-27 |
| Model Number | VITEK 120, 220V |
| Catalog Number | W3202 |
| Operator | OTHER |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | HAZELWOOD MO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-07-27 |