BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS TOUCH DEVICE & POWER SUP

    MDR report key: 10600879 · Received September 29, 2020

    Report

    Report Number
    8043484-2020-03026
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    September 2, 2020
    Report Date
    October 6, 2020
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    UDI-DI
    04582111155092
    PMA / PMN Number
    K153209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL INFORMATION WAS RECEIVED THAT IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE REASSESSMENT DETERMINED THAT THE ISSUE IS A DUPLICATE OF MDR 8043484-2020-02532; THEREFORE, THE EVENT DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. THIS REPORT WAS MADE BASED UPON INFORMATION WHICH SMITH & NEPHEW HAD NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE.

    Additional Manufacturer Narrative · 0

    H10. FURTHER REVIEW OF THIS CASE INDICATES THIS IS A DUPLICATE REPORT. THE EVENT IN THIS REPORT HAS BEEN ALREADY REPORTED UNDER MDR NO. 8043484-2020-02532. ALL FURTHER COMMUNICATION FOR THIS EVENT WILL BE MANAGED IN THAT CASE, INCLUDING A FOLLOW UP REPORT WITH THE RESULTS OF OUR INVESTIGATION. WE RESPECTFULLY REQUEST TO CLOSE THE CASE AS A DUPLICATE AND REFER TO THE REFERENCED CASE ABOVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR, THE RENASYS TOUCH, COULD NOT OPERATE ON AC OR BATTERY POWER AND COULD NOT BE RECHARGED BECAUSE THE J13 CONNECTOR IS BROKEN. NO CASE REPORTED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067537 RENASYS TOUCH DEVICE & POWER SUP NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD. 04582111155092

    Patients

    Seq Age Sex Outcome Treatment
    1