MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-10-07 for COULTER GEN-S SYSTEM 6605381 manufactured by Beckman Coulter, Inc..
[2229270]
The customer had contacted beckman coulter, inc. (bec) to report observing sparking and arcing and detecting an electrical smell coming from their coulter gen-s system. The customer powered off the instrument. There was no impact to patient sample results or patient treatment. The fire department was not called. The customer did not report flames or electrical shock. There was no report of death or serious injury associated with this event. Medical attention was not sought.
Patient Sequence No: 1, Text Type: D, B5
[9368485]
The hospital electrician replaced the plug to the instrument. A field service engineer (fse) was dispatched to the customer's site. The fse observed that the power cord plug into the power supply was burned. The fse examined the ac input receptacle and observed evidence of overheating on the prongs. The fse replaced the ac input assembly and the power cable from the wall outlet to the power supply of the instrument. This reportable event was identified during a retrospective review conducted between january 01, 2008 and october 23, 2010 of complaints for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01654 |
| MDR Report Key | 2320080 |
| Report Source | 01,05,06 |
| Date Received | 2011-10-07 |
| Date of Report | 2009-07-21 |
| Date of Event | 2009-07-21 |
| Date Mfgr Received | 2009-07-21 |
| Device Manufacturer Date | 2000-12-01 |
| Date Added to Maude | 2012-06-29 |
| 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 | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVE. |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER GEN-S SYSTEM |
| Product Code | GKL |
| Date Received | 2011-10-07 |
| Model Number | NA |
| Catalog Number | 6605381 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVE. MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-07 |