inforMED
MalfunctionCCM

AUTOBOX DL

Received Oct 15, 2001 · Event occurred Oct 1, 2001

Report 2050001-2001-00079 · MDR key 356468

Device

Generic name

Plethysmograph

Model number

62/6200/V62

Catalog number

769501

Lot number

-

Product problems

  • Thermal Decomposition of Device
  • Device Emits Odor

Patient

NA

Narrative

Description of Event or Problem

THE OPERATOR OF THE AUTOBOX NOTICED A BURNING SMELL COMING FROM ONE OF ITS CONTROL MODULES. THERE WAS NO PATIENT INVOLVEMENT AND NO INJURIES.