MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2015-09-24 for NAVIOS FLOW CYTOMETER SYSTEM A52103 manufactured by Beckman Coulter Ireland.
[26727564]
A field service engineer (fse) evaluated the gallios instrument at the customer's site. The fse found that an element on the tec slave control board was burnt (charred). Images submitted confirm the event. The board will be replaced when the replacement board is received. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[26727685]
The customer reported a burning smell coming from a gallios flow cytometer system while restarting the instrument. There was no smoke, sparks, arcing or flames reported by the customer. The fire department was not called and there was no death, injury nor need for medical attention as a result of this event. Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event. There was no impact to patient results and controls. This event occurred on the gallios device, which is marketed for research use only (ruo). This report is being filed for similar device, the navios flow cytometer system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2015-01509 |
| MDR Report Key | 5102210 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2015-09-24 |
| Date of Report | 2015-09-07 |
| Date of Event | 2015-09-07 |
| Date Mfgr Received | 2015-09-07 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2015-09-24 |
| 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 | 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 | 2015-09-24 |
| Model Number | NA |
| Catalog Number | A52103 |
| 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 IRELAND |
| Manufacturer Address | LISMEEHAN O'CALLAGHAN'S MILLS, COUNTY CLARE EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-24 |