BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSFORMER,120VAC/60 HZ,8 VDC

    MDR report key: 20787400 · Received November 26, 2024

    Report

    Report Number
    1316463-2024-00156
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    November 21, 2024
    Report Date
    November 26, 2024
    Manufacturer
    WELCH ALLYN INC.
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SPOT VITAL SIGNS LXI MEASURES SYSTOLIC AND DIASTOLIC PRESSURE (EXCLUDING NEONATES), PULSE RATE, TEMPERATURE (ORAL, ADULT AXILLARY, PEDIATRIC AXILLARY, RECTAL, AND EAR), AND PULSE OXIMETRY (SPO2) AS WELL AS CALCULATES MEAN ARTERIAL PRESSURE (MAP). FURTHERMORE, SPOT VITAL SIGNS LXI ALLOWS THE ENTRY OF HEIGHT, WEIGHT, RESPIRATION RATE, AND PAIN LEVEL. SPOT VITAL SIGNS LXI ALSO CALCULATES BODY MASS INDEX (BMI) FOLLOWING HEIGHT AND WEIGHT ENTRY. FOR PROTECTION AGAINST SHOCK, ELECTRICALLY POWERED WELCH ALLYN MEDICAL DEVICES ARE DESIGNED, VALIDATED AND MANUFACTURED PER THE ISOLATION STANDARDS IN "IEC 60601-1". THE STANDARD IS REFERENCED IN THE INSTRUCTIONS FOR USE. THIS ASSURES THAT THE MAINS POWER IS ISOLATED TO PREVENT INJURY TO THE PATIENT AND USER FROM THE MAINS ELECTRICAL POWER. INVESTIGATION OF THE POWER CORD FOUND PHYSICAL DAMAGE ON POWER CORD. ALTHOUGH THE REPORTED EVENT DID NOT RESULT IN A SERIOUS INJURY, THE REPORT OF POWER SUPPLY HAVING FRAYED WIRES COULD CONTRIBUTE TO A SERIOUS INJURY OR DEATH, IF THE MALFUNCTION WERE TO RECUR. THEREFORE, BAXTER CONSIDERS THIS COMPLAINT A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    CUSTOMER REPORTED DEVICE HAD FRAYED WIRES. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2452276 TRANSFORMER,120VAC/60 HZ,8 VDC MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI WELCH ALLYN INC. 5200-101A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown