BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOLLOS

    MDR report key: 13878380 · Received March 24, 2022

    Report

    Report Number
    3008406502-2022-00001
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    January 27, 2022
    Report Date
    March 23, 2022
    Manufacturer
    1073849 ONTARIO LTD. DBA TOLLOS
    Product Code
    FSA
    UDI-DI
    00817956021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INSPECTION INDICATES THAT THE LIMIT SWITCH DID NOT STOP THE UPWARD BELT MOVEMENT AND THE IMPACT WITH THE BOTTOM OF THE LIFT CAUSED THE CLAM SHELL TO BE PUSHED DOWN ON THE LIFTING BELT. FURTHER EVIDENCE IS THAT THE PAINT CHIPS ON THE CLAM SHELL CORRESPOND TO THE LOCATION OF THE SCREW HEADS IN THE BELT GUIDE BLOCK. THE LIMIT SWITCH WAS TESTED REPEATEDLY AND THE FAILURE WAS NOT REPRODUCED. THE BELT GUIDE AND LIMIT SWITCH HAVE BEEN RETURNED TO THE FACTORY AND INSTALLED ON A TEST UNIT TO BE SUBJECT TO CYCLE TESTING TO SEE IF A LIMIT SWITCH FAILURE CAN BE REPRODUCED. THE EFFECTS OF LIMIT SWITCH FAILURE CAN BE SEEN AND SHOULD BE RECOGNIZED BY SERVICE DURING SAFETY INSPECTIONS. IF SEEN, LIFT SHOULD BE TAKEN OUT OF SERVICE UNTIL REPAIRED. FACILITY USES NON-MANUFACTURER SERVICE SO THIS WAS NOT CONTROLLED BY THE MANUFACTURER.

    Description of Event or Problem · 0

    WHILE A PATIENT WAS BEING TRANSFERRED BY TWO STAFF MEMBERS USING THE TOLLOS CIRRUS 600 MODEL LIFT, THE LIFTING STRAP BROKE CAUSING THE PATIENT AND THE SPREADER BAR TO FALL FROM UNSPECIFIED ELEVATION (VERBAL COMMUNICATION INDICATED THAT IT WAS A FEW INCHES). THE PATIENT FELL BACK TO THE BED AND WAS NOT INJURED. THE PATIENT INFORMATION ENTERED IS NOT FACTUAL. THE FACILITY DID NOT PROVIDE THIS INFORMATION. FILLED IN DATA IN ORDER TO PROCEED WITH THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018288 TOLLOS PATEINT LIFT (CEILING LIFT) FSA 1073849 ONTARIO LTD. DBA TOLLOS CIRRUS 600 00817956021

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Prefer Not To Disclose Life Threatening