BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVECARE+SFT

    MDR report key: 6343244 · Received February 20, 2017

    Report

    Report Number
    9616558-2017-00001
    Event Type
    Death
    Date Received
    February 20, 2017
    Date of Event
    January 25, 2017
    Report Date
    January 27, 2017
    Manufacturer
    MEDICAL COMPRESSION SYSTEMS DBN LTD.
    Product Code
    JOW
    PMA / PMN Number
    K151377
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PER CORONER'S FINAL AUTOPSY REPORT, THE OFFICIAL CAUSE OF DEATH WAS "PROBABLE CARDIAC ARRYTHMIA DUE TO CORONARY ATHEROSCLEROSIS, HYPERTENSION, OBESITY, AND RECENT SURGERY."

    Additional Manufacturer Narrative · 1

    THE ACTIVECARE+SFT DEVICE WAS RETURNED BY A FRIEND OF THE DECEASED, BUT THE POWER SUPPLY, SLEEVES, AND EXTENSION TUBES WERE NOT. THE SLEEVES WERE DISCARDED BY THE AUTOPSY TECHNICIAN DUE TO HEAVY SOILING. THE DEVICE WAS VISUALLY INSPECTED AND TESTED PER INTERNAL TEST AND INSPECTION PROTOCOLS. FUNCTIONAL TESTING AND BURN-IN TESTS DID NOT REVEAL ANY FAILURES OR ANOMALIES. DEVICE CYCLING (TIMING) AND PRESSURE LEVELS ARE WITHIN DEFINED RANGES. ADDITIONALLY, REVIEW OF THE SPECIFIC DEVICE HISTORY RECORDS (DHR) INDICATE THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND PASSED ALL IN-PROCESS AND FINAL INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. THE DHR HAD NO INDICATIONS OF NON-CONFORMANCE DURING MANUFACTURE. THE DEVICE USAGE AND USAGE COMPLIANCE WERE ANALYZED. THE LAST PATIENT INFORMATION STORED IN THE DEVICE INDICATED THAT THE TOTAL COMPLIANCE WAS 88% AT 8 DAYS. TREATMENT STARTED ON (B)(6) 2017 (11:36 PM EST) AND FINISHED ON (B)(6) 2017 (APPROXIMATELY 2 AM EST (I.E., 11 PM (B)(6) 2017 PST). DAILY COMPLIANCE: DAYS 1 THROUGH 4 WERE AT 100% DAILY. DAY 5 = 74.4%, DAY 6 = 60.1%, DAY 7 = 100%, DAY 8 = 86%. MCS FAILURE MODE OF "NO FAILURE FOUND" AND MCS ROOT CAUSE CODE OF "NO FAILURE FOUND" WERE ASSIGNED TO THIS COMPLAINT BASED ON RESULTS OF DEVICE INVESTIGATION AND THE FACT THAT THERE WAS NO EVIDENCE IN THE PATIENT'S MEDICAL RECORDS AND IN CONVERSATIONS WITH THE SURGERY STAFF AND PRIMARY CARE PHYSICIAN THAT THE DEVICE HAD MALFUNCTIONED IN ANY WAY. CONCLUSION: THERE WAS NO DEVICE MALFUNCTION AND IT DID NOT CONTRIBUTE TO THE PATIENT OUTCOME (DEATH). OFFICIAL CAUSE OF DEATH IS PENDING THE RETURN OF TOXICOLOGY RESULTS.

    Description of Event or Problem · 1

    PATIENT HAD TOTAL KNEE REPLACEMENT SURGERY DONE ON HER LEFT KNEE ON (B)(6) 2017. PER SURGEON'S NURSE, THE PATIENT HAD NO COMPLICATIONS DURING OR AFTER THE SURGERY. SHE WAS PLACED ON AN ACTIVECARE+SFT COMPRESSION SYSTEM THAT DAY AND WAS PRESCRIBED TO WEAR IT FOR FOURTEEN DAYS. ACCORDING TO COMPLIANCE DATA RECORDED BY THE DEVICE, THE PATIENT WORE THE DEVICE DAILY AS PRESCRIBED. NEITHER HER SURGEON OR HER FAMILY PHYSICIAN WERE CONTACTED BY PATIENT AFTER SURGERY REGARDING ANY PROBLEMS WITH HER RECOVERY OR WITH THE USE OF THE DEVICE. ON (B)(6) 2017, SHE DIED UNATTENDED IN HER HOME IN (B)(6). SHE WAS WEARING HER LEG COMPRESSION SLEEVES WHEN THE BODY WAS FOUND. AN AUTOPSY WAS PERFORMED BY THE COUNTY CORONER ON (B)(6) 2017. THE TOXICOLOGY RESULTS ARE PENDING. THE OFFICIAL CAUSE OF DEATH WILL NOT BE AVAILABLE UNTIL THE RESULTS ARE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125591 ACTIVECARE+SFT COMPRESSIBLE LIMB SLEEVE JOW MEDICAL COMPRESSION SYSTEMS DBN LTD. A502B-0001-01

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death