CELL DYN SAPPHIRE ANALYZER Adverse Event — Malfunction (MDR 2919069-2008-00389)
CELL DYN SAPPHIRE ANALYZER Adverse Event — Malfunction (MDR 2919069-2008-00389) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CELL DYN SAPPHIRE ANALYZER; Generic name: AUTOMATED HEMATOLOGY ANALYZER; Manufacturer: ABBOTT DIAGNOSTICS DIV/ CELL DYN.
| Device | CELL DYN SAPPHIRE ANALYZER |
|---|---|
| Generic name | AUTOMATED HEMATOLOGY ANALYZER |
| Manufacturer | ABBOTT DIAGNOSTICS DIV/ CELL DYN |
| Report number | 2919069-2008-00389 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-21 |
| Report source | Health Professional |
| Narrative | THE CUSTOMER STATED THAT THE VENT HEAD ASSEMBLY OF A CELL-DYN SAPPHIRE WAS SPORADICALLY SHOOTING FLUID INTO THE AIR WHILE RUNNING PT SAMPLES. THE CUSTOMER LOOKED INSIDE THE INSTRUMENT TO OBSERVE THE ACTION OF THE VENT HEAD ASSEMBLY. FLUID DID NOT COME INTO CONTACT WITH THE CUSTOMER AND NO INJURY WAS REPORTED. THE CUSTOMER ALSO OBSERVED THE ASPIRATION PROBE WAS DISPENSING INTO THE WASHCONE INSTEAD |
| Source | openFDA MAUDE (device adverse events) |
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