BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTCARE

    MDR report key: 15083962 · Received July 22, 2022

    Report

    Report Number
    3008058231-2022-00001
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    April 20, 2022
    Report Date
    July 22, 2022
    Manufacturer
    LINET SPOL. S R.O.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    LINET RECEIVED VOLUNTARY FACILITY MALFUNCTION REPORT, MW5110203 ON JUNE 23, 2022. REPORTER STATED, "CORD WAS CAUGHT WHEN BED IN LOWEST POSITION, SPARK AND BURNED BED. NO HARM TO PT, PT MOVED TO ANOTHER BED. FDA SAFETY REPORT ID# (B)(4)." OCCURING ON (B)(6) 2022. BED WAS REPAIRED BY REPORTING FACILITY ON APRIL 21, 2022, WITH FOLLOWING REMARKS, "TROUBLESHOOTING, BED LOWERED ONTO POWER CORD, CUTTING CORD, REPLACED POWER CORD AND CHECKED BED FUNCTIONS." FACILITY PROVIDED THIS EVIDENCE TO LINET AMERICAS ON 6/29/2022 AS WO# (B)(4). THE MULTICARE BED REQUIRES AN EFFECTIVE MAINTENANCE PROGRAM. PREVENTATIVE MAINTENANCE WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR AND TEAR. EXAMINE THE POWER CORDS FOR CUTS, NICKS, BREAKS, FRAYS, AND GROUNDING. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. FACILITY TECHNICIAN REPLACED THE DAMAGE POWER CORD TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    FDA NOTIFIED MANUFACTURER OF REPORT, (MW5110203) WAS RECEIVED THROUGH FDA'S MEDWATCH PROGRAM ON JUNE 23, 2022. THIS REPORT STATED EVENT AS "CORD WAS CAUGHT WHEN BED IN LOWEST POSITION, SPARK AND BURNED BED. NO HARM TO PT, PT MOVED TOANOTHER BED. FDA SAFETY REPORT ID# (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607782 MULTCARE BED, AC-POWERED ADJUSTABLE HOSPITAL FNL LINET SPOL. S R.O. 1MC17350-754

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown