TERUMO CDI 101 MONITOR
Received Aug 30, 2012 · Event occurred Jul 31, 2009
Report 1828100-2012-01172 · MDR key 2724669
Device
Product problems
- Device Emits Odor
- Smoking
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE SCREEN OF UNIT DISPLAYED A "LINE" ACROSS THE SCREEN DURING OPERATION AND THE FUNCTION OF MONITOR IS "OK." THE CUSTOMER SMELLED SMOKE COMING FROM THE MONITOR. THE MONITOR WAS SHUT DOWN AND REPLACED. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PT.
Additional Manufacturer Narrative
THE CUSTOMER'S ENGINEER LATER TURNED ON THE UNIT. AFTER THE MONITOR WAS ON FOR ONE HOUR, SMOKE COULD BE SMELLED COMING FROM THE MONITOR AND THE MONITOR WAS SHUT DOWN. THE REPORTED COMPLAINT WAS CONFIRMED. THE SERVICE REPAIR TECH (SRT) OBSERVED LINE ACROSS SCREEN AND A BURNING SMELL AT STARTUP. THE SRT FOUND THAT THE INVERTER PCBA HAD A SHORTED CAPACITOR. THE CAPACITOR WAS BURNT AS WELL AS THE WIRES ON THE INVERTER PCBA TO OMNI PCBA CABLE. THE SRT REPLACED THE INVERTER PCBA AND INVERTER PCBA TO OMNI PCBA CABLE. WITH THE COMPONENTS REPLACED, THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. BASED ON A REVIEW OF THE INVESTIGATION DETAILS (SMELLED SMOKE BEING RELATED TO BURNT WIRES AND SHORTED CAPACITOR), IS CONSIDERED MDR REPORTABLE. THIS COMPLAINT RECORD IS MORE THAN TWO YEARS OLD AND IS BEING REPORTED AS A RESULT OF A HEALTH HAZARD EVALUATION. IF ADDITIONAL INFO BECOMES AVAILABLE ON THIS COMPLAINT, THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.