MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2015-04-21 for NAVIOS FLOW CYTOMETER SYSTEM A52103 manufactured by Beckman Coulter Ireland.
[5736095]
The customer reported that the violet laser on a navios flow cytometer system stopped working and the operator reported a burning smell coming from the instrument. The customer stopped using the instrument at the time of the event. There were no sparks, arcs, flames or smoke observed at the time of the event. The smell of smoke generated a "code yellow" in the facility and the fire warden tracked the smell back to the navios. The power was removed from the instrument and service was called. Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
[13236771]
A field service engineer (fse) went on site to evaluate the instrument on (b)(4) 2015. The fse found that the laser power control board had failed. The fse found that the connection from the laser power conditioner card to the violet laser controller had a pin that was displaced and an incorrect crimp of the cable on the connection to the power conditioner card. The fse attributes this as the cause of the failure of the laser power control board and the tec slave controller card. A component on the laser power control card did appear to show evidence of charring. The submitted image showed a portion of the board was burned with a melted area and charring evident. The fse repositioned and secured the pin with the correct crimp in the cable and replaced the laser power control board and the tec slave controller card. These actions resolved the problem. The unit is operational. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[43025290]
An internal review revealed that the manufacturing site information submitted in the initial report in manufacturer's phone number was incorrect; the corrected information is provided in this follow-up report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2015-00669 |
| MDR Report Key | 4714688 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-04-21 |
| Date of Report | 2015-03-26 |
| Date of Event | 2015-03-25 |
| Date Mfgr Received | 2016-04-19 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2015-05-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MIRANDA HOLLAND |
| Manufacturer Street | 11800 SW 147TH AVENUE, 32-S08 |
| Manufacturer City | MIAMI FL 331962031 |
| Manufacturer Country | US |
| Manufacturer Postal | 331962031 |
| Manufacturer Phone | 3053802031 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NAVIOS FLOW CYTOMETER SYSTEM |
| Generic Name | FLOW CYTOMETRIC REAGENTS AND ACCESSORIES |
| Product Code | OYE |
| Date Received | 2015-04-21 |
| Model Number | NA |
| Catalog Number | A52103 |
| Lot Number | NA |
| ID Number | SOFTWARE VERSION: 1.2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER IRELAND |
| Manufacturer Address | LISMEEHAN O'CALLAGHAN'S MILLS, CO. CLARE EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-21 |