BEUDAMED
    FDA Adverse Event Death Summary report: N

    PAGEWRITER TC70 CARDIOGRAPH

    MDR report key: 14846409 · Received June 28, 2022

    Report

    Report Number
    1218950-2022-00522
    Event Type
    Death
    Date Received
    June 28, 2022
    Date of Event
    June 2, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    DPS
    UDI-DI
    00884838026582
    PMA / PMN Number
    K113144
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE TC70 INTERPRETED AN ECG INCORRECTLY AND MISSED PROLONGED QT INTERVAL AS THE INTERPRETATION. IT WAS REPORTED THAT THE PATIENT PASSED AWAY LATER THAT DAY AFTER BEING RELEASED FROM THE HOSPITAL.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE TC70 INTERPRETED AN ECG (ELECTROCARDIOGRAM) INCORRECTLY AND MISSED PROLONGED QT INTERVAL AS THE INTERPRETATION. IT WAS REPORTED THAT THE PATIENT PASSED AWAY LATER THAT DAY AFTER BEING RELEASED FROM THE HOSPITAL. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED. PHILIPS TECHNICAL SUPPORT WAS ABLE TO REMOTELY INTERVIEW THE CUSTOMER WITH THE REPORTED PROBLEM VIA PHONE CONVERSATION AND EMAILS. ACCORDING TO THE PROVIDED INFORMATION, ON (B)(6) 2022, PRIOR TO THE PATIENT¿S DISCHARGE, A 12 LEAD ECG WAS PERFORMED TWICE USING A PAGEWRITER TC70 CARDIOGRAPH. THE FIRST ECG WAS TAKEN AT 17:46. THE PH100B VERSION OF THE DXL 12-LEAD ECG ALGORITHM IDENTIFIED ATRIAL FIBRILLATION (AFIB) AND RIGHT BUNDLE BRANCH BLOCK (RBBB), ALSO STATING ABNORMAL ECG WITH AN UNCONFIRMED DIAGNOSIS. THE QT AND QTC VALUES (MEASUREMENT MADE ON THE ELECTROCARDIOGRAM USED TO ASSESS SOME OF THE ELECTRICAL PROPERTIES OF THE HEART) FOR THIS ECG WERE 351 MS AND 502 MS, RESPECTIVELY. NOTE THAT ¿UNCONFIRMED DIAGNOSIS¿ INDICATES THAT THE ECG REPORT WAS NOT OVERREAD BY A QUALIFIED PHYSICIAN. A SECOND ECG WAS TAKEN AT 19:03 WHICH AGAIN SHOWED RBBB, AS WELL AS SINUS RHYTHM AND A BORDERLINE SHORT PR INTERVAL. SIMILARLY, THE READOUT STATED ABNORMAL ECG WITH AN UNCONFIRMED DIAGNOSIS. THE QT AND QTC VALUES FOR THIS ECG WERE 577 MS AND 591 MS, RESPECTIVELY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AT 20:15. FOLLOWING RELEASE FROM THE HOSPITAL THE PATIENT PASSED AWAY, WITH THE CAUSE OF DEATH UNKNOWN. AFTER A REVIEW OF THE ECG PAPER PRINT, IT WAS FOUND THAT THE AUTOMATED INTERPRETATION DID NOT SHOW A PROLONGED QT INTERVAL WHICH, BASED ON THE QTC VALUE FOR BOTH ECGS, SHOULD HAVE OCCURRED. THE DOCTOR BELIEVES THE TC70 INTERPRETED THE ECG INCORRECTLY AND MISSED THE PROLONGED QT INTERVAL ON THE INTERPRETATION STATEMENT. THE DOCTOR STATED THAT HAD THE TC70 PROVIDED THE CORRECT INTERPRETATION, THEY WOULD NOT HAVE SENT THE PATIENT HOME. PER THE DEVICE¿S IFU (INSTRUCTIONS FOR USE), QTC GREATER THAN 465 MS IS CONSIDERED AS BORDERLINE PROLONGED QTC. AN ADDITIONAL 20 MS QUALIFIES THE CONDITION AS PROLONGED QTC. ADDITIONALLY, A SIGNIFICANTLY PROLONGED QTC INTERVAL GREATER THAN 520 MS IS CONSIDERED TO BE DUE TO HYPOCALCEMIA (DEFICIENCY OF CALCIUM IN THE BLOODSTREAM). FOR THE FIRST ECG, A ¿PROLONGED QT INTERVAL¿ STATEMENT SHOULD HAVE DISPLAYED. FOR THE SECOND ECG, A ¿PROLONGED QT INTERVAL SUGGESTS HYPOCALCEMIA¿ STATEMENT SHOULD HAVE DISPLAYED. ACCORDING TO THE HOSPITAL CONTACT, THE SITE DOES NOT HAVE ECG MANAGEMENT SOFTWARE, NOR DO THEY SAVE ECG FILES ON THE DEVICE¿S INTERNAL MEMORY. THE ONLY TECHNICAL READOUTS SAVED BY THE SITE ARE IN THE FORM OF AN ECG PAPER PRINT, WHICH IS SUBSEQUENTLY SCANNED INTO THE MEDICAL RECORD SYSTEM. THEREFORE, IT IS NOT POSSIBLE TO EVALUATE WHY THE ALGORITHM USED DID NOT CORRECTLY GENERATE THE INTERPRETIVE STATEMENT OF PROLONGED QT INTERVAL. AN ISSUE IMPACT ASSESSMENT ((B)(4)) HAS BEEN INITIATED. A 54 COMPLAINT SEARCH (01 JAN 2018 ¿ 01 JULY 2022) FOR PHILIPS CARDIOGRAPH PRODUCTS HAS FOUND ONLY 1 COMPLAINT WHICH DETAILED AS PATIENT SERIOUS INJURY (S3) OR (S4) HARM DEPENDING ON THE CRITERIA ESTABLISHED IN EACH IN-SCOPE SRA. OVER THE SPAN OF THIS 54-MONTH TIMEFRAME, THERE WERE 1,200,731,498 OPPORTUNITIES FOR USE WITH PHILIPS CARDIOGRAPH PRODUCTS. THE OBSERVED RESIDUAL RISK IS WITHIN THE ACCEPTABLE RISK LEVELS ACCORDING TO THE STANDARDS OF THE DXL 12/16 LEAD ECG ALGORITHM SRA DOCUMENT. BASED ON THE CONCLUSION OF THIS ASSESSMENT, NO CORRECTION OR REMOVAL IS REQUIRED. HOWEVER, IT IS RECOMMENDED TO ADD TWO NEW HAZARDOUS SITUATIONS TO ALL IN-SCOPE PRODUCTS¿ SRAS, ONE COVERING A MISSED PROLONGED QT INTERVAL INTERPRETATION STATEMENT, AND ONE COVERING A GENERAL MISSED INTERPRETATION STATEMENT. ANY ADDITIONAL INVESTIGATION OR ACTION TAKEN WILL BE DOCUMENTED IN THE RESPECTIVE RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814247 PAGEWRITER TC70 CARDIOGRAPH PAGEWRITER TC70 CARDIOGRAPH DPS PHILIPS NORTH AMERICA LLC 860315 00884838026582

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Death