BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPONENT MONITORING SYSTEM

    MDR report key: 827729 · Received February 12, 2007

    Report

    Report Number
    9610816-2007-00098
    Event Type
    Death
    Date Received
    February 12, 2007
    Date of Event
    August 13, 2003
    Report Date
    February 12, 2007
    Manufacturer
    PHILIPS MEDIZINSYSTEME BOEBLINGEN
    Product Code
    DPS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    PHILIPS IS IN THE PROCESS OF OBTAINING MORE INFO CONCERNING THIS EVENT AND THIS COMPLAINT IS STILL UNDER INVESTIGATION. THE INFO INDICATING THAT THE MONITOR HAD BEEN PLACED IN PERMANENT SUSPEND MODE, THE INFO THAT DURING THE TIME THE PT'S RESPIRATORY CONDITIONING DETERIORATED, THE ALARMS THEREFORE DID NOT SOUND; AND INFO THAT THE PT SUFFERED RESPITORY ARREST ALL SUPPORTS THAT THE MONITORING WAS A FACTOR IN THE ADVERSE OUTCOME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IN 2003, PT WAS ADMITTED TO A REG MED CTR FOR A HERNIA SURGERY. DUE TO COMPLICATIONS ARISING OUT OF THE SURGERY, PLAINTIFF WAS RE-ADMITTED BACK INTO THE HOSP ON AN EMERGENCY BASIS EIGHT DAYS LATER. IT WAS DISCOVERED UPON RE-ADMISSION TO THE HOSP THAT PT'S BOWEL WAS PERFORATED AND EMERGENCY SURGERY WAS PERFORMED TO REPAIR THE PERFORATE BOWEL. FOLLOWING SURGERY, THE PT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) OF THE HOSP. WHILE IN THE ICU, PT WAS VENTILATOR DEPENDENT. THROUGHOUT THE ENTIRE PT STAY IN THE ICU, THE BEDSIDE MONITOR WAS IN "ALARM SUSPENDED" MODE PREVENTING CRITICAL ALARMS FROM SOUNDING WHEN A CHANGE IN THE PT CONDITION OCCURRED. THIRTEEN DAYS LATER (AFTER 13 DAYS IN ICU), THE ATTENDING PULMONOLOGIST ORDERED THE ICU NURSES TO CHANGE THE VENTILATOR SETTINGS AND BEGIN WEANING THE PT OFF OF THE VENTILATOR. THE PT DID NOT TOLERATE THE REDUCED VENTILATOR SETTINGS AND BECAME VERY ANXIOUS AND AGITATED WHICH RESULTED IN HER PULLING HER BREATHING TUBE OUT. RATHER THAN INTUBATE HER, THE PULMONOLOGIST ORDERED A BREATHING MASK TO BE PLACED ON HER (BIPAP). AGAIN DURING THIS CRITICAL TIME PERIOD, THE PT'S BEDSIDE MONITOR WAS IN "ALARM SUSPENDED" MODE PREVENTING CRITICAL ALARMS FROM SOUNDING. FROM 6:00PM TO 6:17PM, PT'S RESPIRATORY CONDITION DETERIORATED AND SHE BECAME HYPOXIC AND ULTIMATELY SUFFERED RESPIRATORY ARREST. DURING THE 17 MINS, THE PT'S CONDITION CHANGED DRAMATICALLY SUCH THAT THE BEDSIDE MONITOR ALARMS WOULD HAVE SOUNDED IF THEY WERE NOT IN SUSPEND MODE. THUS HER CONDITION WENT UNNOTICED FOR SEVERAL MINS CAUSING HER HYPOXIC CONDITION TO PERSIST. THIS LED TO HER HYPOXIC-ISCHEMIC ENCEPHALOPATHY FROM WHICH SHE DID NOT RECOVER UNTIL HER DEATH IN 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPONENT MONITORING SYSTEM COMPONENT MONITORING SYSTEM DPS PHILIPS MEDIZINSYSTEME BOEBLINGEN M1175A *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death