BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST ES120/220/420

    MDR report key: 10048521 · Received May 12, 2020

    Report

    Report Number
    3006697241-2020-00033
    Event Type
    Malfunction
    Date Received
    May 12, 2020
    Date of Event
    May 5, 2020
    Report Date
    May 5, 2020
    Manufacturer
    HILL-ROM MEXICO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILLROM TECHNICIAN FOUND THE BRAKE SWITCH ASSEMBLY NEEDED TO BE REPLACED. PER THE HILLROM SERVICE MANUAL THE BED SHOULD BE SUBJECT TO AN EFFECTIVE MAINTENANCE PROGRAM. AN ANNUAL SERVICE OF THE BED IS ADVISED IN ORDER TO MAINTAIN ITS CHARACTERISTICS AND PERFORMANCE. PLUG THE BED INTO AN APPROPRIATE POWER SOURCE AND SET THE BRAKES TO NEUTRAL. MAKE SURE THE ALARM IS HEARD. SET THE BRAKES ON THE BED. MAKE SURE THE ALARM STOPS SOUNDING. A SEARCH OF THE HILLROM MAINTENANCE RECORDS DID NOT SHOW HILLROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE BRAKE SWITCH ASSEMBLY TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE BED HAD NO AUDIBLE BRAKE NOT SET ALARM. 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
    509738 CAREASSIST ES120/220/420 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HILL-ROM MEXICO P1170G0000288

    Patients

    Seq Age Sex Outcome Treatment
    1