BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK DRY DOC STATION

    MDR report key: 8492808 · Received April 8, 2019

    Report

    Report Number
    1018233-2019-01767
    Event Type
    Malfunction
    Date Received
    April 8, 2019
    Report Date
    June 14, 2019
    Manufacturer
    PUREWICK CORPORATION ¿ 3012224959
    Product Code
    NZU
    UDI-DI
    00801741151781
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS UNCONFIRMED AS THE PRODUCT IS NOT INTENDED /NOR HAS A FUNCTION FOR THE USER TO CHANGE THE SUCTION LEVEL. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "DRYDOC¿ VACUUM STATION UNPACK AND SETUP ¿ INSPECT THE SHIPPING BOX FOR DAMAGE. IF DAMAGE IS NOTICED, CONTACT LIBERATOR MEDICAL AT 1-888-201-1586 IMMEDIATELY. CAREFULLY REMOVE THE UNIT AND ALL CONTENTS, INCLUDING THE PACKING MATERIAL, FROM THE SHIPPING CONTAINER AND INSPECT CAREFULLY PRIOR TO USE. ¿ PLACE THE DRYDOC¿ VACUUM STATION (A) NEXT TO THE BED OR CHAIR WHERE IT WILL BE USED. IT MUST BE CLOSE ENOUGH FOR THE 70¿ PATIENT TUBING (B) TO EASILY REACH THE USER.* AVOID CREATING A TRIPPING HAZARD WITH THE PATIENT TUBING OR DRYDOC¿ VACUUM STATION. *THE DRYDOC¿ VACUUM STATION SHOULD BE PLACED ON A STABLE AND EVEN SURFACE AT OR BELOW THE USER¿S LEVEL. ¿ PLUG THE DRYDOC¿ VACUUM STATION POWER CORD INTO AN ELECTRICAL OUTLET. ¿ PLACE THE COLLECTION CANISTER (C) IN THE DRYDOC¿ VACUUM STATION BASE AND PRESS DOWN FIRMLY ON THE LID. ATTACH THE 16¿ VACUUM TUBING (D) TO THE DRYDOC¿ VACUUM STATION CONNECTOR PORT (E) AND THE CONNECTOR PORT LABELED ¿VACUUM¿ (F) ON THE COLLECTION CANISTER LID. ¿ ATTACH THE 70¿ PATIENT TUBING (B) TO THE CONNECTOR PORT LABELED ¿PATIENT¿ (G) ON THE COLLECTION CANISTER LID. CONNECT THE OTHER END OF THE 70¿ PATIENT TUBING SECURELY TO PUREWICK¿ FEC (H). CAUTION: IT IS IMPORTANT THAT THE PORT CONNECTIONS BE CONNECTED CORRECTLY FOR PROPER OPERATION OF THE DRYDOC¿ VACUUM STATION. ¿ TURN ON THE DRYDOC¿ VACUUM STATION BY PRESSING THE ON/OFF SWITCH ON TOP OF THE DRYDOC¿ VACUUM STATION. THE DRYDOC¿ VACUUM STATION IS FUNCTIONING WHEN THE SWITCH ILLUMINATES AND THE PUMP MAKES A SOFT HUMMING SOUND. THE SYSTEM IS NOW READY FOR USE." H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SET UP INSTRUCTIONS OF THE PUREWICK DRY DOC STATION WERE "VAGUE". IT WAS UNCLEAR TO THE COMPLAINANT WHETHER TO SET THE DRY DOC TO 40MMHG OR IF THE UNIT CAME PRESET.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SET UP INSTRUCTIONS OF THE PUREWICK DRY DOC STATION WERE "VAGUE". IT WAS UNCLEAR TO THE COMPLAINANT WHETHER TO SET THE DRY DOC TO 40MMHG OR IF THE UNIT CAME PRESET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283612 PUREWICK DRY DOC STATION PUREWICK DRY DOC STATION NZU PUREWICK CORPORATION ¿ 3012224959 NA 00801741151781

    Patients

    Seq Age Sex Outcome Treatment
    1