BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPELLA BARIATRIC BED

    MDR report key: 20445397 · Received October 14, 2024

    Report

    Report Number
    1824206-2024-01448
    Event Type
    Death
    Date Received
    October 14, 2024
    Date of Event
    October 3, 2024
    Report Date
    October 14, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    OSI
    UDI-DI
    00887761000902
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPELLA BARIATRIC BED SYSTEM IS INTENDED TO PROVIDE PATIENT SUPPORT IN HEALTH CARE ENVIRONMENTS AND MAY BE USED IN A VARIETY OF SETTINGS INCLUDING, BUT NOT LIMITED TO, ACUTE CARE, INCLUDING CRITICAL CARE, STEP DOWN/PROGRESSIVE CARE, MEDICAL/SURGICAL, HIGH ACUITY SUB-ACUTE CARE, POST ANESTHESIA CARE UNIT (PACU), AND SECTIONS OF THE EMERGENCY DEPARTMENT (ED). IT IS CAPABLE OF BEING USED WITH A BROAD PATIENT POPULATION AS DETERMINED APPROPRIATE BY THE CAREGIVER OR INSTITUTION AND IS INTENDED FOR PATIENTS BETWEEN 113 KG AND 454 KG (250 LB AND 1000 LB). BAXTER RECEIVED A VOLUNTARY MEDWATCH REPORT ALLEGING A PATIENT DEATH WITH AN UNKNOWN BAXTER BARIATRIC HOSPITAL BED. NO SPECIFIC DEVICE MALFUNCTION WAS REPORTED. NO ADDITIONAL EVENT INFORMATION WAS PROVIDED REGARDING THE MEDICAL SEQUENCE OF EVENTS/CAUSE OF DEATH. ADDITIONALLY, NO DEVICE SERIAL NUMBER, OR REPORTER INFORMATION WAS INCLUDED ON THE MEDWATCH. THE REPORTER DID NOT CONSENT TO FOLLOW UP. IN THIS EVENT, A PATIENT ON AN UNKNOWN BAXTER BARIATRIC HOSPITAL BED DIED. THE CAUSE OF THE EVENT IS UNDETERMINED. BASED ON THE LIMITED DETAILS AVAILABLE AT THE TIME OF THIS EVALUATION, A DEVICE MALFUNCTION CANNOT BE RULED OUT. THEREFORE, BAXTER CONSIDER THIS TO A BE A REPORTABLE EVENT FOR THE FDA.

    Description of Event or Problem · 0

    BAXTER RECEIVED A MEDWATCH NOTIFICATION #MW5160277 NOTING THAT COMPELLA CAP US SCALE PPM HAD A PATIENT DISEASE. NO SPECIFIC DEVICE MALFUNCTION WAS REPORTED. NO ADDITIONAL EVENT INFORMATION WAS PROVIDED REGARDING THE MEDICAL SEQUENCE OF EVENTS/CAUSE OF DEATH. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810604 COMPELLA BARIATRIC BED BARIATRIC BED OSI BAXTER HEALTHCARE CORPORATION P7800A NI 00887761000902

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death