inforMED
MalfunctionDPZ

NSATX

Received Mar 24, 2017 · Event occurred Jan 31, 2017

Report 6431454 · MDR key 6431454

Device

Generic name

Oximeter

Manufacturer

Ge Healthcare

Product problems

  • Defective Alarm
  • Unable to Obtain Readings

Patient

0 YR

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

PATIENT WAS PLACED ON NEW SPO2 MODULE PER TEMPORARY UPDATE. (NEW SPO2 PROBE WAS PLACED ON PATIENT AT THIS TIME AS WELL). THE RN NOTICED THAT PROBE WAS NOT PICKING UP OR READING SATURATIONS, AND WAS WITHOUT WAVEFORM, DURING PATIENT ACTIVITY THAT MAY OR MAY NOT HAVE BEEN ACCOMPANIED BY DESATURATION. MODULE ON MONITOR DID NOT ALARM AT THIS TIME. UNABLE TO READ SATURATION MODULE UNTIL DISCONNECTED FROM TEMPORARY MODULE AND RECONNECTED BACK TO MAIN PATIENT DATA MODULE (PDM).