BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVE CLINICAL PLATFORM

    MDR report key: 17317585 · Received July 13, 2023

    Report

    Report Number
    2027454-2023-00052
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    June 16, 2023
    Report Date
    October 3, 2023
    Manufacturer
    HILL-ROM CARY
    Product Code
    MWI
    UDI-DI
    00856128007007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE WAVE CLINICAL PLATFORM IS SOFTWARE INTENDED TO ROUTE, STORE, AND DISPLAY DATA, ALARMS, RESULTS AND DIAGNOSTIC INFORMATION FROM MEDICAL DEVICES, ELECTRONIC MEDICAL RECORDS (EMR), AND CLINICAL INFORMATION SYSTEMS (CIS). THE WAVE CLINICAL PLATFORM IS A REMOTE MONITORING PLATFORM THAT DISPLAYS PHYSIOLOGIC DATA, WAVEFORMS, ALARMS, RESULTS, AND DIAGNOSTIC INFORMATION ROUTED THROUGH THE PLATFORM FROM SUPPORTED DEVICES AND SYSTEMS. THE WAVE CLINICAL PLATFORM IS INTENDED FOR USE IN HOSPITAL OR HOSPITAL TYPE ENVIRONMENTS. THE WAVE CLINICAL PLATFORM IS INTENDED TO BE USED BY HEALTHCARE PROFESSIONALS FOR THE FOLLOWING PURPOSES: TO REMOTELY CONSULT REGARDING PATIENTS¿ STATUSES. TO REMOTELY REVIEW OTHER STANDARD OR CRITICAL NEAR REAL-TIME PATIENT DATA, WAVEFORMS, ALARMS, AND RESULTS IN ORDER TO UTILIZE THIS INFORMATION TO AID IN CLINICAL DECISIONS. THE WAVE CLINICAL PLATFORM IS INTENDED TO SUPPLEMENT AND NOT REPLACE ANY PART OF THE HOSPITAL'S DEVICE MONITORING OR ELECTRONIC DATA MANAGEMENT SYSTEMS. DO NOT RELY ON THE WAVE CLINICAL PLATFORM PRODUCT AS THE SOLE SOURCE OF ALARMS. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE WAVE CLINICAL PLATFORM IS SOFTWARE INTENDED TO ROUTE, STORE, AND DISPLAY DATA, ALARMS, RESULTS AND DIAGNOSTIC INFORMATION FROM MEDICAL DEVICES, ELECTRONIC MEDICAL RECORDS (EMR), AND CLINICAL INFORMATION SYSTEMS (CIS). THE WAVE CLINICAL PLATFORM IS A REMOTE MONITORING PLATFORM THAT DISPLAYS PHYSIOLOGIC DATA, WAVEFORMS, ALARMS, RESULTS AND DIAGNOSTIC INFORMATION ROUTED THROUGH THE PLATFORM FROM SUPPORTED DEVICES AND SYSTEMS. THE WAVE CLINICAL PLATFORM IS INTENDED FOR USE IN HOSPITAL OR HOSPITAL TYPE ENVIRONMENTS. THE WAVE CLINICAL PLATFORM IS INTENDED TO BE USED BY HEALTHCARE PROFESSIONALS FOR THE FOLLOWING PURPOSES: TO REMOTELY CONSULT REGARDING PATIENTS¿ STATUSES; TO REMOTELY REVIEW OTHER STANDARD OR CRITICAL NEAR REAL-TIME PATIENT DATA, WAVEFORMS, ALARMS, AND RESULTS IN ORDER TO UTILIZE THIS INFORMATION TO AID IN CLINICAL DECISIONS. THE USER MANUAL CONTAINS WARNINGS SUCH AS "THE WAVE CLINICAL PLATFORM IS INTENDED TO SUPPLEMENT AND NOT REPLACE ANY PART OF THE HOSPITAL'S DEVICE MONITORING OR ELECTRONIC DATA MANAGEMENT SYSTEMS. DO NOT RELY ON THE WAVE CLINICAL PLATFORM PRODUCT AS THE SOLE SOURCE OF ALARMS". THE HRC TECHNICIAN UPGRADED THE WAVE FOR THE CUSTOMER TO RESOLVE THE ISSUE. ALTHOUGH THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT, IF THE REPORTED ISSUE WERE TO RECUR IT COULD LEAD TO INJURY OR DEATH. THEREFORE HILLROM IS REPORTING THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A WEBSOCKET 1006 ERROR AND MESSAGE WAS NEVER SENT IN A DISPATCH EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A WEBSOCKET 1006 ERROR AND MESSAGE WAS NEVER SENT IN A DISPATCH EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171256 WAVE CLINICAL PLATFORM MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI HILL-ROM CARY 00856128007007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown