BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORTARA

    MDR report key: 7893696 · Received September 20, 2018

    Report

    Report Number
    2183461-2018-00003
    Event Type
    Injury
    Date Received
    September 20, 2018
    Date of Event
    June 29, 2018
    Report Date
    August 21, 2018
    Manufacturer
    MORTARA INSTRUMENT, INC
    Product Code
    DPS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED 2 PDF FILES OF THE ECG OBTAINED ON (B)(6) 2018 AT 07:32:26. THE FIRST PDF IS AN ECG WITH AN UNCONFIRMED, DEVICE PROVIDED INTERPRETATION OF ATRIAL FIBRILLATION AND NONSPECIFIC T-WAVE ABNORMALITY. IN THE SECOND PDF, THE PHYSICIAN FOLLOWED THE EXPECTED WORKFLOW. HE REMOVED THE INTERPRETATION STATEMENT PROVIDED BY THE DEVICE BASED ON HIS OVER-READ OF THE PATIENT'S WAVEFORM. THE PHYSICIAN ADDED HIS INTERPRETATION ANALYSIS TO THE ECG AND THEN ELECTRONICALLY SIGNED THE REPORT. THE PHYSICIAN'S INTERPRETATION OF THE ECG DID NOT INCLUDE ATRIAL FIBRILLATION. HE READ THE ECG AS SINUS RHYTHM WITH FIRST DEGREE AV BLOCK WITH OCCASIONAL SUPERVENTRICULAR PREMATURE COMPLEXES, NONSPECIFIC T-WAVE ABNORMALITY. PER THE DEVICES INSTRUCTIONS FOR USE, THE INTERPRETATION STATEMENT PROVIDED BY THE DEVICE IS FOR CONSIDERATION ONLY AFTER REVIEW BY A PHYSICIAN, TO BE USED IN CONJUNCTION WITH ALL OTHER RELEVANT PATIENT DATA AND IS NOT A SOLE MEANS FOR DIAGNOSIS AND/OR TREATMENT. THE CUSTOMER WAS CONTACTED MULTIPLE TIMES; HOWEVER, NO ADDITIONAL INFORMATION REGARDING THIS EVENT COULD BE OBTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER ACQUIRED AN ELECTROCARDIOGRAM (ECG) WITH THE ELI 380. THE INTERPRETATION STATEMENT PROVIDED BY THE ELI 380 DEVICE STATED ATRIAL FIBRILLATION. BASED ON THE INTERPRETATION STATEMENT, THE PATIENT WAS GIVEN A CALCIUM CHANNEL BLOCKER. THE CUSTOMER ALLEGES THAT THE PATIENT EXPERIENCED A CARDIAC ARREST SECONDARY TO MEDICATION. REVIEW OF THE ECG WAVEFORM SHOWED THAT THE PATIENT WAS NOT IN ATRIAL FIBRILLATION AND THEREFORE THE PATIENT MAY NOT HAVE REQUIRED THE CALCIUM CHANNEL BLOCKER. PER THE PHYSICIAN THE PATIENT DID NOT HAVE ATRIAL FIBRILLATION BUT DID HAVE SEPSIS AND SINUS TACHYCARDIA. IT IS UNKNOWN WHETHER THE PATIENT HAD ANY RISK FACTORS FOR CARDIAC ARREST IN ADDITION TO THE CALCIUM CHANNEL BLOCKER. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733975 MORTARA ELECTROCARDIOGRAPH DPS MORTARA INSTRUMENT, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R