BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 5698647 · Received June 3, 2016

    Report

    Report Number
    1060680-2016-00012
    Event Type
    Malfunction
    Date Received
    June 3, 2016
    Date of Event
    May 11, 2016
    Report Date
    May 27, 2016
    Manufacturer
    RONDISH COMPANY LIMITED
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE SAMPLE WAS RETURNED FOR THIS CUSTOMER COMPLAINT. AS REPORTED, THE UNITS ARE NOT TURNING ON AT ALL. SEVERAL DIFFERENT BATTERIES WERE TRIED BY DIFFERENT INDIVIDUALS, THE UNITS WILL NOT POWER UP. THE VENDOR WAS SENT A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) FOR THE SAME ISSUE FOR TWO PREVIOUS COMPLAINTS (REF. MDR 1060680-2016-00002). THE VENDOR STATED THE ROOT CAUSE WAS A BAD SOLDER CONNECTION. A CONNECTION POINT WAS BROKEN CAUSING DISRUPTION. THIS ISSUE WAS FOUND IN APRIL 2013 AND ACTIONS WERE TAKEN AT THE TIME TO CORRECT THE PROBLEM. THE RETURNED UNITS FOR THIS COMPLAINT WERE PRODUCED IN APRIL 2013, AND ARE STRONGLY SUSPECTED TO HAVE THE SAME ISSUE AS UNITS TESTED BY VENDOR. THE VENDOR SCAR IS ATTACHED. THERE IS ANOTHER MDR BEING SUBMITTED AT THE SAME TIME AS THIS ONE FOR THE SAME ISSUE AND PART NUMBER, FROM THE SAME VENDOR. THIS IS MDR 1060680-2016-00011. LOT FROM THE CURRENT INVENTORY ON HAND (1242732) WAS REVIEWED/TESTED AT RANDOM, ALL UNITS REVIEWED POWERED UP WITH NO ISSUES. ROOT CAUSE: THE VENDOR STATED THAT THE ROOT CAUSE WAS A BAD SOLDER CONNECTION. THE CONNECTION POINT WAS BROKEN CAUSING DISRUPTION. CORRECTIONS: REPLACEMENT PRODUCT WAS REQUESTED AND SENT. CORRECTIVE ACTION: ADDITIONAL QUALITY CONTROL STEPS WERE IMPLEMENTED BY THE VENDOR. SINCE THE PRODUCT FOR THIS COMPLAINT WAS FROM A LOT PRODUCED BEFORE QUALITY CONTROL STEP WAS PUT INTO PLACE, THERE WERE NO FURTHER ACTIONS REQUIRED AT THIS TIME. PREVENTIVE ACTION: THERE IS NO ACTION REQUIRED 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 · 1

    THE QUALITY ISSUE DETAILS AND THE OUTCOME DETAILS SECTION COPIED BELOW ARE RESPONSES GIVEN BY THE INITIAL REPORTER TO THE DEROYAL COMPLAINT QUESTIONNAIRE. DATE OF OCCURRENCE: (B)(6) 2016. WHEN DID QUALITY ISSUE OCCUR? DURING USE. WHO WAS USING OR OPERATING THE PRODUCT WHEN THE QUALITY ISSUE OCCURRED? HEALTH PROFESSIONAL. WAS A MEDICAL PROCEDURE INVOLVED? NO. NAME OF MEDICAL PROCEDURE: NOT APPLICABLE. DID THE QUALITY ISSUE CAUSE A DELAY IN THE MEDICAL PROCEDURE? NOT APPLICABLE. DETAILED DESCRIPTION OF QUALITY ISSUE: ALARM QUIT FUNCTIONING. NO LIGHTS, NOISE ETC. CHANGED BATTERIES AND TESTED ALARM. HOW WAS THE QUALITY ISSUE WAS IDENTIFIED? BY VISUAL INSPECTION. HOW WAS THE PRODUCT BEING USED? FALL PREVENTION. WAS IT THE INITIAL USE OF THE PRODUCT? NO. WAS THE PRODUCT MODIFIED FROM THE ORIGINAL CONDITION SUPPLIED BY DEROYAL? NO. WAS THE PRODUCT CONNECTED TO OR USED IN CONJUNCTION WITH OTHER DEVICES OR EQUIPMENT? NO. OUTCOME(S) ATTRIBUTED TO QUALITY ISSUE: NONE. PERSON(S) AFFECTED BY OUTCOME(S) CHECKED ABOVE: NONE. KNOWN PRE-EXISTING CONDITION(S) OF PERSON(S) AFFECTED: NONE SPECIFIED. WAS THE INCIDENT REPORTED TO THE FDA? NO. DETAILED DESCRIPTION OF OUTCOME(S), INCLUDING INFORMATION REGARDING INJURY OR ANY ADDITIONAL TREATMENT/INTERVENTION REQUIRED: ALARM QUIT FUNCTIONING. NO LIGHTS, NOISE ETC. CHANGED BATTERIES AND TESTED ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351960 DEROYAL MONITOR, FALL GUARD, SAFETY AUTO RE-SET KMI RONDISH COMPANY LIMITED M2100-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other