MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-06 for COULTER? GEN-S? SYSTEM 6605381 manufactured by Beckman Coulter.
[4108493]
The customer reported that a laboratory personnel smelled smoke coming from the coulter gen-s system. The customer was unable to identify where the smell was coming from on the instrument. There were no visible arcs, sparks, or flames in connection with this event. The customer stated that no one was injured and the fire extinguisher was not used. The customer contacted the fire department. No erroneous results were generated and there was no change or affect to patient treatment in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
[11328246]
A beckman coulter field service engineer (fse) was dispatched to the customer's site. The fse evaluated the instrument and discovered that the right side of the analyzer's power supply was not working. The fse traced the problem to the analyzer's crt screen backplane. The fse unplugged the crt screen which allowed the power supply to work but the analyzer microcontroller card (amc) would not initialize. The fse ordered the crt screen and the amc board for a return visit and returned to the customer's site to replace the crt screen and amc board to resolve the issue. Results: crt screen and amc board. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2013-02765 |
| MDR Report Key | 3504095 |
| Report Source | 05,06 |
| Date Received | 2013-12-06 |
| Date of Report | 2013-11-07 |
| Date of Event | 2013-11-07 |
| Date Mfgr Received | 2013-11-07 |
| Device Manufacturer Date | 2000-04-01 |
| Date Added to Maude | 2014-03-11 |
| 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. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| 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 |
| Generic Name | COUNTER, CELL, AUTOMATED (PARTICLE COUNTER) |
| Product Code | GKL |
| Date Received | 2013-12-06 |
| Model Number | NA |
| Catalog Number | 6605381 |
| Lot 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 |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-06 |