BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE MRS W/O X-RAY

    MDR report key: 16834782 · Received April 28, 2023

    Report

    Report Number
    3006697241-2023-00037
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    March 31, 2023
    Report Date
    September 20, 2023
    Manufacturer
    HILL-ROM MEXICO
    Product Code
    IOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THE SEAT SECTION IS WEARING DOWN ON THE PRO PLUS MATTRESS WITH USE ON A VERSACARE FRAME. DURING HILLROM¿S INSPECTION OF THE DEVICE, ACCOUNT CONFIRMED THAT THERE WAS NO INJURY TO A PATIENT. INSPECTION OF THE MATTRESS BY HILLROM FOUND THE MATTRESS WAS WORKING PROPERLY. THE FOAM IN THE MATTRESS WAS NOTED TO BE WORN. BASED ON THE LIMITED DETAILS AVAILABLE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. ADDITIONALLY, AT THIS TIME FUNCTIONALITY OF THE DEVICE CANNOT BE CONFIRMED AS THIS INVESTIGATION IS STILL ONGOING TO DETERMINE SPECIFIC DETAILS OF THE REPORTED EVENT. IF ANY ADDITIONAL RELEVANT DETAILS ARE RECEIVED; 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 CUSTOMER REPORTED THE SEAT SECTION IS WEARING DOWN ON THE PRO PLUS MATTRESS WITH USE ON A VERSACARE FRAME. DURING HILLROM¿S INSPECTION OF THE DEVICE, ACCOUNT CONFIRMED THAT THERE WAS NO INJURY TO A PATIENT. INSPECTION OF THE MATTRESS BY HILLROM FOUND THE MATTRESS WAS WORKING PROPERLY. THE FOAM IN THE MATTRESS WAS NOTED TO BE WORN. BASED ON THE LIMITED DETAILS AVAILABLE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. ADDITIONALLY, AT THIS TIME FUNCTIONALITY OF THE DEVICE CANNOT BE CONFIRMED AS THIS INVESTIGATION IS STILL ONGOING TO DETERMINE SPECIFIC DETAILS OF THE REPORTED EVENT. IF ANY ADDITIONAL RELEVANT DETAILS ARE RECEIVED FOLLOWING THE COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE SEAT SECTION IS WEARING DOWN ON THE PRO PLUS MATTRESS WITH USE ON A VERSACARE FRAME. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE SEAT SECTION IS WEARING DOWN ON THE PRO PLUS MATTRESS WITH USE ON A VERSACARE FRAME. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417434 VERSACARE MRS W/O X-RAY BED, FLOTATION THERAPY, POWERED IOQ HILL-ROM MEXICO P3255A02

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown