BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    P3200 VERSACARE BED

    MDR report key: 15537511 · Received October 4, 2022

    Report

    Report Number
    1824206-2022-00436
    Event Type
    Malfunction
    Date Received
    October 4, 2022
    Date of Event
    September 29, 2022
    Report Date
    October 4, 2022
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INITIALLY REPORTED THAT THE VERSACARE BED'S EXIT ALARM DIDN'T ALARM WHEN THE PATIENT EXITED THE BED, IT WAS ASSUMED THE PATIENT WAS INJURED. DURING A FOLLOW-UP CALL WITH THE CUSTOMER, THE CUSTOMER STATED THAT HE CONTACTED HILLROM TO OBTAIN INFORMATION AS TO HOW THE BED'S EXIT ALARM WORKED. THE EVENT REPORTED TO HILLROM ON SEPTEMBER 29, 2022 WAS ALLEGED TO HAVE OCCURRED IN (B)(6) 2000 HOWEVER DURING FOLLOW UP WITH THE CUSTOMER THEY NOTED THEY WERE UNSURE WHEN THIS EVENT, IF ANY, OCCURRED. THE CUSTOMER STATED THAT THERE WAS POSSIBLY AN EVENT TWO YEARS PRIOR TO THE CALL, HOWEVER, DID NOT KNOW WHAT TYPE OF BED, THE SEQUENCE OF EVENTS, THE LOCATION OF THE EVENT, IF THERE WAS PATIENT INVOLVEMENT, OR IF AN INJURY OCCURRED. A HILLROM BED IS INTENDED FOR USE IN HEALTHCARE ENVIRONMENTS AS A PATIENT SUPPORT SYSTEM. SOME BEDS MAY BE EQUIPPED WITH AN EXIT ALERT FEATURE. THIS EXIT ALERT PROVIDES AN AUDIBLE AND VISUAL ALERT NOTIFICATION TO THE CAREGIVER TEAM IF THE PATIENT WERE TO EXIT THE BED. HOWEVER, IT IS NOT INTENDED AS A SUBSTITUTE FOR GOOD NURSING PRACTICES. THE BED EXIT ALARM SYSTEM MUST BE USED IN CONJUNCTION WITH A SOUND RISK ASSESSMENT AND PROTOCOL. OF NOTE: THE CAREGIVER MUST ENGAGE A HILLROM BED'S EXIT ALARM SYSTEM MANUALLY, PRIOR TO ITS ABILITY TO PROVIDE AN ALERT. IN THIS EVENT, THE CUSTOMER DID NOT PROVIDE THE NECESSARY DETAILS TO DETERMINE THE SEVERITY OF THE EVENT, IF THE EVENT INVOLVED A HILLROM BED OR IF THE BED'S EXIT ALARM WAS PROPERLY ENGAGED PRIOR TO THE EVENT. ADDITIONALLY, BASED ON THE LIMITED DETAILS AVAILABLE, THERE WAS NO INDICATION THAT A SERIOUS INJURY OCCURRED. IF ANY ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, THE COMPLAINT WILL BE ADDRESSED ACCORDINGLY. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT THE VERSACARE BED'S EXIT ALARM DIDN'T ALARM WHEN THE PATIENT EXITED THE BED, IT WAS ASSUMED THE PATIENT WAS INJURED. DURING A FOLLOW-UP CALL WITH THE CUSTOMER, THE CUSTOMER STATED THAT HE CONTACTED HILLROM TO OBTAIN INFORMATION AS TO HOW THE BED'S EXIT ALARM WORKED. THE CUSTOMER STATED THAT THERE WAS POSSIBLY AN EVENT TWO YEARS PRIOR TO THE CALL, HOWEVER, DID NOT KNOW WHAT TYPE OF BED, THE SEQUENCE OF EVENTS, THE LOCATION OF THE EVENT, IF THERE WAS PATIENT INVOLVEMENT, OR IF AN INJURY OCCURRED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2778828 P3200 VERSACARE BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HILL-ROM BATESVILLE P3200D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown