BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRELLA MED-SURG

    MDR report key: 16314036 · Received February 7, 2023

    Report

    Report Number
    1824206-2023-00057
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    January 17, 2023
    Report Date
    February 7, 2023
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    FNL
    UDI-DI
    00887761985162
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THE CENTRELLA BED HAD INTERFERENCE WITH A TELEMETRY BOX SHOWING FALSE INCREASED HEART RATE AND ARRHYTHMIAS. THERE WAS NO ALLEGATION OF PATIENT OR CAREGIVER INJURY, OR DEATH REPORTED FROM THIS ALLEGED INCIDENT; HOWEVER UNNECESSARY TREATMENT DID OCCUR. IT WAS REPORTED THAT THE PATIENT WAS SLEEPING ON THEIR RIGHT SIDE WITH THE TELE BOX LYING NEXT TO THEM (VERSUS IN THE GOWN POCKET) AND THE TELEMETRY MONITOR DISPLAYED WHAT WOULD LOOK LIKE AN INCREASE IN HEART RATE AND ARRHYTHMIA WHICH CAUSED THE MONITOR TO GO OFF AT THE NURSE¿S STATION. WHEN THE NURSE WENT IN TO ASSESS, THE PATIENT WAS SLEEPING AND ASYMPTOMATIC. THE PATIENT WAS PLACED ON THEIR BACK, A 12 LEAD EKG WAS COMPLETED, LABS WERE OBTAINED (PHOSPHORUS & MAGNESIUM) AND THE MD WAS NOTIFIED. THE BED WAS INSPECTED BY THE CUSTOMER BIO-MED, EDUCATION WAS PROVIDED TO STAFF AND A WARNING TAG WAS PLACED ON THE BED-INDICATING WATCH CARE SYSTEM MAY CAUSE INTERFERENCE WITH TELEMETRY. THE CUSTOMER ADDITIONALLY NOTED THAT THE WATCH CARE SYSTEM WAS DISABLED BY A HILLROM REPRESENTATIVE THE FOLLOWING DAY, PER FA-2022-043 WATCHCARE MODIFICATION. THE WATCHCARE INCONTINENCE MANAGEMENT SYSTEM (SYSTEM) PROVIDES A DISCREET VISUAL ALERT AND OPTIONAL EQUIPMENT CALL ALERTS AFTER MOISTURE IS DETECTED ON THE WATCHCARE SMART PAD. THE INCONTINENCE MONITOR IS INTENDED TO DETECT AND PROVIDE A TIMELY ALERT WHEN THE PATIENT¿S SKIN IS EXPOSED TO INCONTINENCE (BOTH URINE AND LIQUID FECAL EVENTS). THE DEVICE IFU NOTES THE FOLLOWING CAUTION ON ELECTROMAGNETIC EMISSIONS GUIDANCE AND INTERFERENCE: (1) THE WATCHCARE READER, INDICATOR LIGHT, AND ANTENNAS IS AN INTENTIONAL RADIATOR OF RF ENERGY. THEREFORE, ITS RF EMISSIONS ARE LOW AND MAY CAUSE INTERFERENCE IN NEARBY ELECTRONIC EQUIPMENT (2) CAUTION¿THIS DEVICE MEETS ALL REQUIREMENTS FOR ELECTROMAGNETIC COMPATIBILITY PER IEC 60601-1-2. IT IS UNLIKELY THAT THE USER WILL ENCOUNTER PROBLEMS WITH THIS DEVICE BECAUSE OF INADEQUATE ELECTROMAGNETIC IMMUNITY. HOWEVER, ELECTROMAGNETIC IMMUNITY IS ALWAYS RELATIVE, AND STANDARDS ARE BASED ON ANTICIPATED ENVIRONMENTS OF USE. IF THE USER OBSERVES UNUSUAL DEVICE BEHAVIOUR, PARTICULARLY IF SUCH BEHAVIOUR IS INTERMITTENT AND ASSOCIATED WITH NEARBY USE OF RADIO OR TV TRANSMITTERS, CELL PHONES, OR ELECTRO-SURGICAL EQUIPMENT, THIS COULD BE AN INDICATION OF ELECTROMAGNETIC INTERFERENCE. IF SUCH BEHAVIOUR OCCURS, THE USER SHOULD TRY TO MOVE THE INTERFERING EQUIPMENT FURTHER FROM THIS DEVICE. WITH THIS EVENT, THERE WAS NO REPORT OF AN INJURY; HOWEVER DUE TO WATCHCARE INTERFERENCE OF THE TELEMETRY DEVICE, UNNECESSARY TREATMENT OF AN EKG AND LABS WERE PERFORMED. IF ELECTROMAGNETIC INTERFERENCE WERE TO RECUR BETWEEN WATCHCARE AND TELEMETRY SYSTEMS OR OTHER DEVICES, IT IS LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH AS THIS BEHAVIOUR MAY NOT BE RECOGNIZED BY THE CAREGIVER RESULTING IN OMISSION AND/OR UNNECESSARY MEDICAL INTERVENTION. THEREFORE, HILLROM CONSIDERS THIS COMPLAINT REPORTABLE.

    Description of Event or Problem · 0

    HILLROM RECEIVED A REPORT FROM THE CUSTOMER STATING THE WATCHCARE WAS INTERFERING WITH THE TELEMETRY SYSTEM AND SHOWING FALSE INCREASED HEART RATE AND ARRHYTHMIAS. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO ALLEGATION OF PATIENT OR CAREGIVER INJURY, OR DEATH REPORTED FROM THIS ALLEGED INCIDENT; HOWEVER UNNECESSARY TREATMENT DID OCCUR. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126513 CENTRELLA MED-SURG BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HILL-ROM BATESVILLE P7900B200195 00887761985162

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown