inforMED
MalfunctionDPZ

OXIMAX N-560 PULSE OXIMETER

Received Mar 28, 2014 · Event occurred Mar 1, 2014

Report 2936999-2014-00244 · MDR key 3817475

Device

Generic name

Pulse Oximeter

Manufacturer

Mediana

Model number

N-560

Catalog number

N-560

Product problems

  • No Display/Image
  • Component Missing

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

(B)(4). UPON INVESTIGATION THE REPORTED INTERMITTENT FAULT WAS VERIFIED, AND ISOLATED TO CRACKED SOLDER JOINTS ON BOTH THE FRONT BOARD AND MAIN PCB BOARD.

Description of Event or Problem

RECEIVED A REPORT OF A N-560 WITH A MISSING SEGMENT AND INTERMITTENT SEGMENTS OF THE DISPLAY. NO PATIENT HARM WAS REPORTED.