BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PST 500

    MDR report key: 19689199 · Received July 8, 2024

    Report

    Report Number
    3007143268-2024-00029
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Date of Event
    June 13, 2024
    Report Date
    July 23, 2024
    Manufacturer
    BAXTER MEDICAL SYSTEMS GMBH + CO. KG
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INSPECTION OF THE DEVICE IS PENDING AND RESULTS WILL BE PROVIDED BY A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE OF BAXTER PERFORMED AN ON-SITE INVESTIGATION AT THE HOSPITAL. THE FAILURE TABLE TOP TIPPED TO THE LEFT SIDE COULD BE CONFIRMED DURING THE INSPECTION. THE FAILURE WAS RESOLVED BY REPLACING THE TABLE. THE CAUSE OF THE FAULT IS A SPRING PIN #(B)(4) FALLING OUT. THIS WAS LOCATED IN THE TABLE'S CHASSIS. THE SPRING PIN HAS THE TASK OF CONNECTING THE SPINDLE OF THE MOTOR WITH THE FORK HEAD EDGE MOUNT OF THE TABLE TOP. IF THIS FALLS OUT, THE TABLE TOP MOUNT CAN LOOSEN UPWARDS FROM THE SPINDLE. THIS WILL CAUSE THE TABLETOP TO TILT DOWN. THE REPORTED ISSUE IS A KNOWN FAILURE AND IS CURRENTLY INVESTIGATED THROUGH NCR 2903531. THE PST 500 MEDICAL DEVICE IS A MOBILE, CONFIGURABLE OPERATING TABLE INTENDED TO BE USED WITH ADDITIONAL, SPECIFIC TABLETOP SECTIONS, PADS, AND ACCESSORIES TO POSITION PATIENTS DURING SURGERY, FROM THE ADMINISTRATION OF ANESTHETIC TO THE ACTUAL SURGERY AND RECOVERY FROM ANESTHETIC. ALTHOUGH THIS EVENT DID NOT RESULT IN PATIENT INJURY, IF THE REPORTED INCIDENT WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE, BAXTER IS REPORTING THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PST 500 OPERATING TABLE SUDDENLY TIPPED TO THE LEFT SIDE DURING A THORACIC SURGICAL PROCEDURE AND SURGICAL STAFF COULD NOT CHANGE THE POSITION OF THE TABLE. THE PATIENT WAS STABILIZED ON THE TABLE WITH STRAPS AND ARM BOARDS. THE SURGERY WAS DELAYED APPROXIMATELY 30 MINUTES, BUT THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH THE PATIENT IN A 28° TILT. THERE WAS NO HARM TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PST 500 OPERATING TABLE SUDDENLY TIPPED TO THE LEFT SIDE DURING A THORACIC SURGICAL PROCEDURE AND SURGICAL STAFF COULD NOT CHANGE THE POSITION OF THE TABLE. THE PATIENT WAS STABILIZED ON THE TABLE WITH STRAPS AND ARM BOARDS. THE SURGERY WAS DELAYED APPROXIMATELY 30 MINUTES, BUT THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH THE PATIENT IN A 28° TILT. THERE WAS NO HARM TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835054 PST 500 TABLE, OPERATING-ROOM, ELECTRICAL GDC BAXTER MEDICAL SYSTEMS GMBH + CO. KG 4080100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown