BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESQCPR SYSTEM

    MDR report key: 5444840 · Received February 18, 2016

    Report

    Report Number
    3000143502-2016-00001
    Event Type
    Injury
    Date Received
    February 18, 2016
    Date of Event
    January 16, 2016
    Report Date
    January 21, 2016
    Manufacturer
    ADVANCED CIRCULATORY
    Product Code
    PIZ
    PMA / PMN Number
    P110024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN (B)(6) PATIENT IN A NURSING HOME WAS BEING FED BY STAFF. THEY TURNED AWAY AND SOME TIME LATER FOUND HER IN CARDIAC ARREST WITH ASYSTOLE. CPR WAS STARTED BY THE NURSING HOME STAFF. EMS THEN ARRIVED AND USED RESQCPR INCLUDING THE RESQPUMP. A WOUND/INJURY ON THE PATIENT'S CHEST (SKIN TEAR) WAS OBSERVED AFTER THAT. THIS WAS COVERED WITH A CLEAR PLASTIC BANDAGE. IT IS UNCERTAIN WHETHER THE INJURY WAS ATTRIBUTABLE TO THE USE OF THE RESQPUMP. EMS PERSONNEL CONTINUED WITH MANUAL CPR AND THE RESQPOD AND SHE WAS TRANSPORTED WITHOUT A PULSE AND IN ASYSTOLE WITH ONGOING CPR TO BAPTIST EMERGENCY DEPARTMENT WHERE SHE WAS DECLARED DEAD. DEATH WAS NOT ATTRIBUTED TO THE USE OF THE RESQPUMP OR THE OBSERVED DAMAGE TO THE CHEST. EMS REPORTED COMPRESSIONS WERE PERFORMED AT A DEPTH OF 2.5 INCHES DURING USE OF RESQPUMP WHICH IS GREATER THAN DESCRIBED IN THE INSTRUCTIONS FOR USE OF 1.5 TO 2.0 INCHES OR 33 TO 45 KG.

    Description of Event or Problem · 1

    AN (B)(6) PATIENT IN A NURSING HOME WAS BEING FED BY STAFF. THEY TURNED AWAY AND SOME TIME LATER FOUND HER IN CARDIAC ARREST WITH ASYSTOLE. CPR WAS STARTED BY THE NURSING HOME STAFF. EMS THEN ARRIVED AND USED RESQCPR INCLUDING THE RESQPUMP. A WOUND/INJURY ON THE PATIENT'S CHEST (SKIN TEAR) WAS OBSERVED AFTER THAT. THIS WAS COVERED WITH A CLEAR PLASTIC BANDAGE. IT IS UNCERTAIN WHETHER THE INJURY WAS ATTRIBUTABLE TO THE USE OF THE RESQPUMP. EMS PERSONNEL CONTINUED WITH MANUAL CPR AND THE RESQPOD AND SHE WAS TRANSPORTED WITHOUT A PULSE AND IN ASYSTOLE WITH ONGOING CPR TO BAPTIST EMERGENCY DEPARTMENT WHERE SHE WAS DECLARED DEAD. DEATH WAS NOT ATTRIBUTED TO THE USE OF THE RESQPUMP OR THE OBSERVED DAMAGE TO THE CHEST. EMS REPORTED COMPRESSIONS WERE PERFORMED AT A DEPTH OF 2.5 INCHES DURING USE OF RESQPUMP WHICH IS GREATER THAN DESCRIBED IN THE INSTRUCTIONS FOR USE OF 1.5 TO 2.0 INCHES OR 33 TO 45 KG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100775 RESQCPR SYSTEM RESQCPR SYSTEM PIZ ADVANCED CIRCULATORY 12-0823-000

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other