inforMED
MalfunctionOUL

C1000 (TOUCH) THERMAL CYCLER CHASSIS

Received Jul 18, 2016 · Event occurred Jun 8, 2016

Report MW5063473 · MDR key 5802101

Device

Generic name

Thermal Cycler

Manufacturer

Bio-rad

Model number

C1000

Product problems

  • Fire
  • Smoking
  • Defective Component
  • Sparking
  • Noise, Audible

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

ON (B)(6) 2016, (B)(6) STAFF REPORTS, HEARD POPPING COMING FROM THERMAL CYCLER. UNIT STARTED SPARKING AND SMOKING. SPARKS AND FLAMES WERE NEAR THE POWER SWITCH. UNIT SERIAL NUMBER (B)(4). UNIT RETURNED TO BIO-RAD FOR REPAIR. ACCORDING TO BIO-RAD THE MALFUNCTION THAT CAUSED THE SPARKS, POPPING NOISE AND FLAMES IS DUE TO A DEFECTIVE POWER SUPPLY. BIO-RAD DID NOT ISSUE A RECALL BECAUSE OF A LESS THAN (b)(4) FAILURE RATE, AND THOUGHT THAT ISSUE IS CONTAINED TO A POWER SUPPLY ENCLOSURE.