BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 15214600 · Received August 11, 2022

    Report

    Report Number
    3007215625-2022-01203
    Event Type
    Malfunction
    Date Received
    August 11, 2022
    Date of Event
    May 30, 2022
    Report Date
    December 5, 2023
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FIELD SERVICE WAS PERFORMED. EXTERNAL VISUAL INSPECTION: OUTSIDE LIQUID COOLANT STICK AND DUSTY. LEFT AND RIGHT-SIDE LOWER PANEL SCRATCH. OUTSIDE LOWER BASE SCRATCH. INCOMING TEST: I WAS PERFORMED INSPECTION, DIAGNOSTIC TESTING WITH RMA ADAPTER AND APPLICATOR RMA UNIT TURN ON RUNNING WELL INTERNAL INSPECTION: INTERNAL THE INSPECTION MEASURE UPPER AND LOWER BOTH 12V POWER SUPPLY AND CHECK ALL CABLES TO ENSURE SECURE WITH NO PROBLEM ALL CABLE LOOKING GOOD SECURE. I FOUND LIQUID COOLANT LEAK INSIDE THE UPPER. SUMMARY OF REPAIR DETAIL: UPDATE BOARDS OF UPPER UNIT. RE TIGHTEN CHILLER TUBE. RETEST AND CLEAN UP THE SYSTEM. ROOT CAUSE: I CONFIRM THE COSTUMER¿S COMPLAINT. RE TIGHTEN CHILLER TUBE. RETEST. UNIT RUN WELL. PARTS REPLACED: FOR LOWER: 200179 BOTTLE COOLANT BRZ-RP1-DLC-001 STANDALONE CRATE LOWER EN11955 CU BAG 206263 FILTER EN15643 RIGHT LOWER PANEL EN15644 LEFT LOWER PANEL. FOR UPPER: BRZ-RP1-DUC-001 CRATE UPPER EN11955 CU BAG 200455 COMPUTER BASE BOARD EN10606 CF CARD 200498 CONTROL INTERFACE BOARD. CLEAN UP THE SYSTEM WITH ALPHA WIPES PAINT TOUCHUP CYCLE POWER TESTED 3 MINS QUICK ENGINEERING CHECK PROFILE WAS RUN TO VERIFY PROPER OPERATION. THE CYCLE COMPLETED WITHOUT ERROR. 45MIN CYCLE POWER MFG BUN IN TESTED GOOD 80 HOURS DURATION TEST RUNNING 3 HOURS COMPLETE TESTED GOOD NO SHOW UP ANY ERROR ANALYZER TESTING SHOW ALL CHANNEL 1-6 ARE GOOD IN TEMPERATURE, AND TEC DATA. CURRENTS ARE GOOD ADDITIONAL TESTS: CHILLER DIAGNOSTIC TEST: PASSED VACUUM DIAGNOSTIC TEST: PASSED PAGING SYSTEM TEST: PASSED TOUCHSCREEN TEST & CALIBRATION: PASSED PERFORMED FINAL TEST PASS. BASED ON THE INFORMATION CURRENTLY AVAILABLE, TECHNICAL REVIEW, AND LABORATORY INSPECTION, ALTHOUGH NO ADVERSE EVENT WAS REPORTED, THERE IS THE POSSIBILITY OF: SKIN IRRITATION/ HYPERSENSITIVITY, ELECTRIC SHOCK, THERMAL INJURY FROM HOT OR COLD COOLANT, BRUISING FROM SLIP HAZARD, AND FRACTURE. IT CAN BE CONCLUDED THAT THE LEAKAGE OF COOLANT FROM THE FAILURE IDENTIFIED POSE LOW RISKS OF DISCUSSED HARMS AND MODERATE RISK OF FRACTURE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF AND WHEN ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D1.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A LEAK WITH THE COOLSCULPTING CONTROL UNIT. THERE WAS NO PATIENT OR PROVIDER SAFETY IMPACT.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A LEAK WITH THE COOLSCULPTING CONTROL UNIT. THERE WAS NO PATIENT OR PROVIDER SAFETY IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326362 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown