BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VSM6800/SPN/ST/RADIO/PLUG66

    MDR report key: 14188614 · Received April 22, 2022

    Report

    Report Number
    1316463-2022-00054
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    December 15, 2021
    Report Date
    April 22, 2022
    Manufacturer
    WELCH ALLYN INC.
    Product Code
    MWI
    UDI-DI
    00732094192575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CVSM IS INTENDED TO BE USED BY CLINICIANS AND MEDICALLY QUALIFIED PERSONNEL FOR MONITORING OF NEONATAL, PEDIATRIC, AND ADULT PATIENTS' NONINVASIVE BLOOD PRESSURE, PULSE RATE, NONINVASIVE FUNCTIONAL OXYGEN SATURATION OF ARTERIOLAR HEMOGLOBIN, AND BODY TEMPERATURE IN NORMAL AND AXILLARY MODES. THE MOST LIKELY LOCATIONS FOR PATIENTS TO BE MONITORED ARE GENERAL MEDICAL AND SURGICAL FLOORS, GENERAL HOSPITAL, AND ALTERNATE CARE ENVIRONMENTS. THE MONITOR PRESENTS PHYSIOLOGICAL ALARMS AND TECHNICAL ALARMS. PHYSIOLOGICAL ALARMS OCCUR WHEN VITAL SIGN MEASUREMENTS FALL OUTSIDE OF SET ALARM LIMITS (IN THE CONTINUOUS MONITORING AND INTERVALS MONITORING PROFILES ONLY) AND TECHNICAL ALARMS OCCUR WHEN THERE IS A PROBLEM WITH THE MONITOR, AN ACCESSORY CONNECTED TO THE MONITOR, OR THE NETWORK. TECHNICAL ALARMS OCCUR IN ALL PROFILES. THE CVSM CAN COMMUNICATE THE PHYSIOLOGICAL ALARMS BASED ON THE CONFIGURATIONS PROGRAMMED BY THE USER. THE DEVICE INSTRUCTIONS FOR USE LISTS THE FOLLOWING WARNINGS REGARDING ELECTRICAL SHOCK HAZARDS: (1) DISCONNECT AC POWER BEFORE OPENING THE DEVICE. DISCONNECT AND REMOVE THE BATTERY BEFORE PROCEEDING WITH DISASSEMBLY. FAILURE TO DO THIS CAN CAUSE SERIOUS PERSONAL INJURY AND DAMAGE TO THE DEVICE. (2) BEFORE CLEANING THE MONITOR, DISCONNECT THE AC POWER CORD FROM THE MAIN OUTLET AND THE POWER SOURCE. THE NURSE RECEIVED AN ELECTRICAL SHOCK FROM THE EVENT WITH NO MEDICAL INTERVENTION REQUIRED. THE CUSTOMER LISTS THE CAUSE OF OCCURRENCE AS, ¿PLUGGING AND UNPLUGGING WITHOUT TURNING OFF SWITCH¿ AND NOTES THE DEVICE PASSED ALL TESTING INCLUDING EST. PROCEDURES FOR PREVENTION OF SHOCK ARE OUTLINED IN THE DEVICE USER MANUAL AS NOTED ABOVE. THE SEVERITY OF SHOCK FROM A GIVEN SOURCE WILL DEPEND UPON ITS PATH THROUGH THE BODY. LOW VOLTAGE (LESS THAN OR EQUAL TO 380 VOLTS) ELECTRIC CURRENTS THAT PASS THROUGH THE BODY HAVE WELL-DEFINED PHYSIOLOGIC EFFECTS. FOR A 1 SECOND CONTACT TIME, 1 MA IS THE THRESHOLD OF PERCEPTION ¿ CAUSING A TINGLING SENSATION: OR 5MA CAUSING A MAXIMUM HARMLESS CURRENT. IT IS LIKELY THE OPERATOR EXPERIENCED DISCOMFORT OR PAIN. PAIN IS AN UNPLEASANT SENSATION OCCURRING IN VARIOUS DEGREES AND TYPICALLY STOPS ONCE THE STIMULUS IS REMOVED. PAIN IS A SYMPTOM, NOT AN INJURY. BASED ON THE DETAILS PROVIDED BY THE CUSTOMER, THE REPORTED SHOCKING SENSATION AND ANY PAIN ASSOCIATED WITH THE SHOCKING SENSATION WERE ONLY NOTED FOR A ¿SHORT WHILE.¿ THE CVSM WAS INSPECTED AND TESTED BY THE HOSPITAL BIOMEDICAL SERVICE (ATTACHED VIA DL OF ETQ). POSSIBLE CAUSE IS LISTED AS: ¿PLUGGING AND UNPLUGGING WITHOUT TURNING OFF SWITCH.¿ EVIDENCE OF, ¿CORROSION/PITTING ON ACTIVE, NEUTRAL, EARTH PINS OF THE POWER CORD¿ WAS NOTED AND PHOTOS SENT. IT IS ADDITIONALLY DOCUMENTED THAT THE DOUBLE GENERA-PURPOSE OUTLET (DGPO) IN THE CORRIDOR WAS REPLACED DUE TO AN INTERNAL SHORT. THE DEVICE PASSED ALL TESTING INCLUDING EST AND WAS RETURNED TO CLINICAL USE WITH A NEW POWER CORD. THE EVENT WAS NOT LIFE-THREATENING, AND THERE WAS NO INDICATION THAT THE EVENT RESULTED IN SERIOUS INJURY OR PERMANENT IMPAIRMENT OF A BODY FUNCTION OR STRUCTURE. HOWEVER, DUE TO THE POTENTIAL FOR SERIOUS INJURY TO OCCUR WITH REOCCURRENCE, HILLROM IS CAUTIOUSLY REPORTING THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN PULLING THE POWER CORD OF A CONNEX VITAL SIGN MONITOR (CVSM) 6800 FROM THE WALL SOCKET, THE NURSE RECEIVED AN ELECTRIC SHOCK. THE CUSTOMER CONFIRMED ASSESSMENT OF THE NURSE OCCURRED WITH NO MEDICAL INTERVENTION REQUIRED FROM THE EVENT. THE CUSTOMER STATES, ¿AS THE NURSE PULLED OUT THE CVSM DEVICE FROM THE POWER POINT A BIG SPARK CAME OUT OF THE POWER POINT¿ AND SHOCKED THE NURSE¿S RIGHT HAND UP TO THE ELBOW. THE NURSES THUMB AND POINTER FINGER CONTINUED TO FEEL NUMB FOR A SHORT WHILE FOLLOWING THE EVENT. THIS EVENT HAS BEEN CAPTURED UNDER HILLROM REF # C-(B)(6)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742621 VSM6800/SPN/ST/RADIO/PLUG66 MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI WELCH ALLYN INC. 68NXTX-6 00732094192575

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown