BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO II NPWT PUMP

    MDR report key: 18797717 · Received February 28, 2024

    Report

    Report Number
    1060680-2024-00001
    Event Type
    Malfunction
    Date Received
    February 28, 2024
    Date of Event
    January 27, 2024
    Report Date
    April 26, 2024
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    OMP
    UDI-DI
    00749756781053
    PMA / PMN Number
    K112458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS RECEIVED ON 1/30/2024 REPORTING "I HAVE HAD YOUR NWT WOUND VAC SINCE (B)(6) 2024. WE HAVE NOT BEEN ABLE TO KEEP A DRESSING ON FOR MORE THAN FIVE HOURS. THAT IS WITH THREE DIFFERENT EXPERIENCED REGISTERED NURSES AND ONE DOCTOR ATTEMPTING TO APPLY IT. DUE TO THESE PROBLEMS YOUR MACHINE HAS CAUSED A SKIN BREAKDOWN." THIS INVESTIGATION IS ONGOING AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS RECEIVED ON 1/30/2024 REPORTING "I HAVE HAD YOUR NWT WOUND VAC SINCE (B)(6) 2024. WE HAVE NOT BEEN ABLE TO KEEP A DRESSING ON FOR MORE THAN FIVE HOURS. THAT IS WITH THREE DIFFERENT EXPERIENCED REGISTERED NURSES AND ONE DOCTOR ATTEMPTING TO APPLY IT. DUE TO THESE PROBLEMS YOUR MACHINE HAS CAUSED A SKIN BREAKDOWN." THE COMPLAINT SAMPLE WAS RECEIVED AND DIAGNOSTICS TESTING WAS PERFORMED ON THE DEVICE. TESTING INDICATES THAT THE COMPLAINT SAMPLE WAS WORKING PROPERLY. THE UNITS FIRMWARE WAS UPDATED TO CURRENT REVISION AND THE UNIT WAS RETURNED TO OSF HOME CARE SERVICES. THE POTENTIAL ROOT CAUSE WAS DETERMINED TO BE AN APPLICATION ERROR REGARDING THE DRESSING. THE CUSTOMER STATED THAT THE DEVICE ALARMED WHEN USED WHICH IS A RISK CONTROL FOR POOR DRESSING APPLICATION. DEROYAL PROVIDES A USER MANUAL AND TROUBLE SHOOTING CARD WITH THE UNIT UPON PURCHASE TO HELP THE END USER UNDERSTAND HOW TO OPERATE AND FUNCTION THE DEVICE. DEROYAL WILL CONTINUE TO MONITOR THROUGH THE COMPLAINT HANDLING SYSTEM. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    I HAVE HAD YOUR NWT WOUND VAC SINCE (B)(6) 2024. WE HAVE NOT BEEN ABLE TO KEEP A DRESSING ON FOR MORE THAN 5 HOURS WITH THREE DIFFERENT EXPERIENCED REGISTERED NURSES AND ONE DOCTOR ATTEMPTING TO APPLY IT. DUE TO THESE PROBLEMS YOUR MACHINE HAS CAUSED SKIN BREAKDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741716 PRO II NPWT PUMP NEGATIVE PRESSURE WOUND THERAPY PUMP (OMP) OMP DEROYAL INDUSTRIES, INC. NP-2000 00749756781053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown