inforMED
MalfunctionOUL

S1000 THERMAL CYCLER CHASSIS

Received Jul 18, 2016 · Event occurred Jun 17, 2016

Report MW5063495 · MDR key 5802608

Device

Generic name

Thermal Cycler

Manufacturer

Bio-rad

Model number

S1000

Product problems

  • Defective Device

Patient

Not reported

  • No Patient Involvement
  • No Patient Involvement

Narrative

Description of Event or Problem

ON (B)(6) 2016 BIO-RAD REP NOTIFIED (B)(6) THAT ADD'L UNITS COULD HAVE THE SAME MALFUNCTION (DEFECTIVE POWER SUPPLY) AND INSTRUCTED (B)(6) EQUIPMENT MANAGEMENT STAFF TO RETURN UNIT SERIAL NUMBER (B)(4) TO BIO-RAD FOR REPAIR.