BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIQ E9

    MDR report key: 7973862 · Received October 17, 2018

    Report

    Report Number
    3005860720-2018-00002
    Event Type
    Injury
    Date Received
    October 17, 2018
    Report Date
    November 28, 2018
    Manufacturer
    SEE H10
    Product Code
    IYN
    PMA / PMN Number
    K152309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S CASTER MALFUNCTION HAS BEEN CORRECTED, AND GE'S PRODUCT COMPLAINT INVESTIGATION HAS CONCLUDED. GE'S COMPLAINT DATABASE WAS SEARCHED FOR INJURIES ASSOCIATED WITH THE LOGIQ E9 CASTER FALLING OFF MALFUNCTION AND NO OTHER COMPLAINTS WERE FOUND. ALSO, COMPLAINT DATA WAS SEARCHED FOR TRENDS OF THE MALFUNCTION OF THE CASTER FALLING OFF ULTRASOUND CONSOLES AND NO TREND WAS IDENTIFIED. HOWEVER, A SEPARATE INVESTIGATION WAS INITIATED DUE TO THE CASTER FALLING OFF AND THIS SEPARATE INVESTIGATION RESULTED IN A PROCESS IMPROVEMENT STEP AT THE CASTER SUPPLIER. THIS PROCESS IMPROVEMENT STEP AT THE SUPPLIER HAS PROVEN TO BE EFFECTIVE, ENSURING CASTERS DO NOT FALL OFF ULTRASOUND CONSOLES, AND IT IS CURRENTLY IN EFFECT. ADDITIONALLY, THE PRODUCT COMPLAINT INVESTIGATION'S ROOT CAUSE OF THE INJURY ASSOCIATED WITH THE CASTER FALLING OFF THE LOGIQ E9 IS ATTRIBUTED TO NOT ADHERING TO GE'S USER MANUAL. A REVIEW OF RISK MITIGATIONS CONCLUDES THEY ARE EFFECTIVE AND THE RISK MITIGATIONS ASSOCIATED WITH THE POTENTIAL FOR HARM WHEN A CASTER FALLS OFF THE LOGIQ E9 IS ALARP, AND NO FURTHER ACTIONS ARE NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 1

    GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC. UNIQUE IDENTIFIER: (B)(4). GE'S INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A REAR CASTOR FELL OFF A LOGIQ E9 AND A USER/SONOGRAPHER LIFTED THE SYSTEM WHILE ANOTHER REPLACED THE WHEEL. THE PERSON LIFTING THE SYSTEM CLAIMED SHE INJURED HER BACK WHILE DOING THIS BUT DID NOT SEEK TREATMENT. THEN ONE OR TWO DAYS LATER WHILE WORKING SHE COLLAPSED AND/OR FELL ON THE FLOOR WITH BACK PAIN, AND RAPID RESPONSE WAS CALLED. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE INJURY OTHER THAN TO SAY THE INJURED WAS CURRENTLY RECEIVING CHIROPRACTIC CARE AND PHYSICAL THERAPY TO ADDRESS THE BACK INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815172 LOGIQ E9 LOGIQ E9 DIAGNOSTIC ULTRASOUND IYN SEE H10 ULGE9C 200924US6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other