BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 4052697 · Received September 2, 2014

    Report

    Report Number
    3015876-2014-01029
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    July 27, 2014
    Report Date
    August 4, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K052057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS BEEN UNABLE TO PROVIDE THE SERIAL NUMBER THAT BELONGS TO THE DEVICE ASSOCIATED WITH THE REPORTED EVENT. A CLINICAL REVIEW OF THE FILE WAS PERFORMED ON THE INFORMATION AVAILABLE AND IT WAS DETERMINED THAT DUE TO THE UNKNOWN DOWNTIME OF THE PATIENT AND THE POSSIBILITY THAT THE ELECTRODES WERE IMPROPERLY PLACED BY THE DEVICE END USER, THAT THE DEVICE USE DID NOT CONTRIBUTE TO THE OUTCOME OF THE PATIENT. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDWATCH REPORT INDICATES: THE CUSTOMER HAS BEEN UNABLE TO PROVIDE THE SERIAL NUMBER THAT BELONGS TO THE DEVICE ASSOCIATED WITH THE REPORTED EVENT. A CLINICAL REVIEW OF THE FILE WAS PERFORMED ON THE INFORMATION AVAILABLE AND IT WAS DETERMINED THAT DUE TO THE UNKNOWN DOWNTIME OF THE PATIENT AND THE POSSIBILITY THAT THE ELECTRODES WERE IMPROPERLY PLACED BY THE DEVICE END USER, THAT THE DEVICE USE DID NOT CONTRIBUTE TO THE OUTCOME OF THE PATIENT. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56. THE INITIAL MEDWATCH REPORT SHOULD INDICATE: AFTER MUCH INVESTIGATION THE CUSTOMER WAS UNABLE TO PROVIDE THE SERIAL NUMBER THAT BELONGED TO THE DEVICE THAT WAS ASSOCIATED WITH THE REPORTED PATIENT EVENT. AS A RESULT, PHYSIO-CONTROL EXAMINED ALL THREE (3) OF THE CUSTOMER'S DEVICES. PHYSIO WAS UNABLE TO DUPLICATE OR VERIFY THE REPORTED ISSUE WITH ANY OF THEIR DEVICES. ALL THREE (3) DEVICES PASSED FUNCTIONAL AND PERFORMANCE TESTING WITH NO DISCREPANCIES OBSERVED. THE DEVICES WERE THEN RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER, A POLICE OFFICER, CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A RECENT EVENT INVOLVING PATIENT USE, THEIR LIFEPAK® 500 AED (¿THE DEVICE¿) CONTINUALLY PROMPTED THE DEVICE OPERATOR TO ¿CONNECT ELECTRODES.¿ THE PATIENT, A (B)(6) FEMALE WITH A HISTORY OF DRUG AND ALCOHOL ABUSE, WAS FOUND UNCONSCIOUS AND UNRESPONSIVE. THE EVENT WAS UNWITNESSED AND THE FIRST RESPONDERS FOUND PHYSICAL EVIDENCE SUGGESTING THAT THE PATIENT MAY HAVE CONSUMED BOTH AMBIEN AND ALCOHOL PRIOR TO THE EVENT. UPON ARRIVAL, THE CUSTOMER ATTACHED A SET OF PHYSIO BRAND DEFIBRILLATION ELECTRODES TO THE PATIENT AND THE DEVICE. ONCE POWERED ON, THE DEVICE CONTINUALLY STATED TO ¿CONNECT ELECTRODES¿ AND DID NOT DETECT THAT THE PATIENT WAS ATTACHED. A BACKUP DEVICE WAS RETRIEVED IN WHAT THE CUSTOMER COULD ONLY DESCRIBE AS ¿LESS THAN 5 MINUTES.¿ THE BACKUP DEVICE, ALSO A LIFEPAK® 500, AND A NEW SET OF PHYSIO BRAND DEFIBRILLATION ELECTRODES WERE THEN PLACED ON THE PATIENT AND THE DEVICE WAS ABLE TO ANALYZE THE PATIENT AND PROVIDED A SHOCK ADVISED DECISION. THE PATIENT WAS THEN DEFIBRILLATED USING THE BACKUP DEVICE. THE POLICE OFFICER WHO REPORTED THE EVENT ADVISED THAT BEYOND THE FIRST DEFIBRILLATION SHOCK HE WAS UNAWARE OF HOW MANY (IF ANY) ADDITIONAL DEFIBRILLATION SHOCKS WERE PROVIDED TO THE PATIENT. HE WAS ALSO UNAWARE OF WHAT KIND OF TREATMENT THE PATIENT RECEIVED AFTER CARE WAS TRANSFERRED TO THE LOCAL EMS AGENCY WHO THEN TRANSPORTED THE PATIENT TO A HOSPITAL. THE POLICE OFFICER WHO REPORTED THE EVENT ALSO ADVISED THAT HE BELIEVED THAT THE CAUSE OF THE REPORTED ISSUE WAS IMPROPER ELECTRODE PLACEMENT; HOWEVER THERE IS NO WAY TO VERIFY THIS INFORMATION. THE PATIENT DID NOT SURVIVE THE EVENT; HOWEVER, IT IS UNKNOWN WHEN, AFTER THE EVENT, THAT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533335 BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR