BEUDAMED
    FDA Adverse Event Death Summary report: N

    NELLCOR

    MDR report key: 8458238 · Received March 27, 2019

    Report

    Report Number
    8020893-2019-00072
    Event Type
    Death
    Date Received
    March 27, 2019
    Date of Event
    March 1, 2019
    Report Date
    February 2, 2021
    Manufacturer
    MITG - GALWAY
    Product Code
    DQA
    PMA / PMN Number
    K123581
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE EVALUATION FOUND NO POTENTIALLY CONTRIBUTING FACTORS, AND THE SAMPLE MET ALL RELATED SPECIFICATIONS. IT WAS REPORTED THAT THE DEVICE GAVE AN INCORRECT PULSE RATE READING. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE IDENTIFIED BECAUSE NO RELATED PROBLEM WAS DETECTED WITH THE DEVICE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE GAVE AN INCORRECT PULSE RATE READING. THE PHYSICIAN DETECTED THAT THE PATIENT HAD LOW SPO2 AND ON THE CONTROL, THE HEART BEAT WAS ZERO BUT ON THE DEVICE, THE HEART BEAT WAS 100 BEATS PER MINUTE. THE PATIENT IS DECEASED. THE DEVICE IS NOT SUSPECTED OF CAUSING PATIENT DEATH. IN FOLLOW UP FOR ADDITIONAL INFORMATION THE CUSTOMER STATED THE PATIENT¿S MEDICAL HISTORY INCLUDES THE PATIENT WAS 1 MONTH WEIGHING 3 KG WITH CONGENITAL HEART DISEASE OPERATION, ANOMALY AND PERFUSION FAILURE. THE PATIENT WAS RECEIVING POSITIVE PRESSURE MECHANICAL VENTILATION FROM A DRAEGER VENTILATOR. THE INTERVENTION THEY PERFORMED WAS ADMINISTRATION OF ADRENALIN AND THEN STARTED CPR. THE PATIENT¿S CAUSE OF DEATH WAS CARDIAC ARREST ON (B)(6) 2019. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE GAVE AN INCORRECT PULSE RATE READING. THE PHYSICIAN DETECTED THAT THE PATIENT HAD LOW SPO2 AND ON THE CONTROL, THE HEART BEAT WAS ZERO BUT ON THE DEVICE, THE HEART BEAT WAS 100 BEATS PER MINUTE. THE PATIENT IS DECEASED. THE DEVICE IS NOT SUSPECTED OF CAUSING PATIENT DEATH. IN FOLLOW UP FOR ADDITIONAL INFORMATION THE CUSTOMER STATED THE PATIENT¿S MEDICAL HISTORY INCLUDES THE PATIENT WAS (B)(6) MONTH WEIGHING (B)(6) KG WITH CONGENITAL HEART DISEASE OPERATION, ANOMALY AND PERFUSION FAILURE. THE PATIENT WAS RECEIVING POSITIVE PRESSURE MECHANICAL VENTILATION FROM A DRAEGER VENTILATOR. THE INTERVENTION THEY PERFORMED WAS ADMINISTRATION OF ADRENALIN AND THEN STARTED CPR.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE GAVE AN INCORRECT PULSE RATE READING. THE PHYSICIAN DETECTED THAT THE PATIENT HAD LOW SPO2 AND ON THE CONTROL, THE HEART BEAT WAS ZERO BUT ON THE DEVICE, THE HEART BEAT WAS 100 BEATS PER MINUTE. THE PATIENT IS DECEASED. IT IS UNKNOWN IF THE PATIENT'S DEATH IS RELATED TO THE DEVICE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251461 NELLCOR OXIMETER DQA MITG - GALWAY N600

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Death