inforMED
InjuryDRT

FUKUDA DENSHI

Received Jun 4, 2009 · Event occurred May 29, 2009

Report MW5011476 · MDR key 1401918

Device

Generic name

Bedside Patient Monitor

Model number

DS-7300

Product problems

  • Device Alarm System
  • Repair
  • Self-Activation or Keying

Patient

51 YR

  • Loss of consciousness

Narrative

Description of Event or Problem

POSSIBLE DELAY IN INITIATING A CODE RESPONSE. RT WEANED PT FROM VENT 15 MINS PRIOR TO EVENT, STEPPED OUT OF ROOM AND UPON RETURN TO DRAW ABG, FOUND PATIENT UNRESPONSIVE AND BEDSIDE MONITOR WITH ALL ZEROS. NO AUDIBLE ALARMS NOTED. MAIN DESK MONITOR CHECKED AND NOTED THAT THE HEART RATE ALARM WAS OFF AND WHEN TURNED ON AT THE NURSING STATION, THE ALARM TURNED ITSELF OFF IMMEDIATELY. THIS OCCURRED MULTIPLE TIMES. FUKUDA WAS CALLED AND GUIDED THROUGH THE CONFIGURATION SETTINGS. THE PROBLEM WAS THAT THE CONFIGURATION FOR HEART RATE ALARM SOURCE WAS SET ON SPO2 AND NOT ON ECG ON THE BEDSIDE MONITOR.