BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIMLINE DISPOSABLE BLOOD PRESSURE CUFF

    MDR report key: 3067961 · Received April 12, 2013

    Report

    Report Number
    1316463-2013-00006
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    January 10, 2013
    Report Date
    March 14, 2013
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    DXQ
    PMA / PMN Number
    K080189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BP CUFF HAS BEEN DISCARDED, AND WILL NOT BE RETURNED TO WELCH ALLYN FOR EVAL. ACCORDING TO THE COMPLAINANT, THE PT WAS CONNECTED TO A UNK MODEL DRAEGER DEVICE THAT PERFORMED THE BP MEASUREMENTS DURING SURGERY. SINCE THE CUFF WAS DISCARDED, THE ACTUAL SIZE OF THE CUFF USED IS UNK. THE COMPLAINANT STATED THAT THEY REPORTED THE MATERIAL NUMBER TO IDENTIFY THE TYPE OF CUFF BUT THEY HAVE NO RECORD OF THE SIZE USED. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFO ON THIS EVENT. WELCH ALLYN DOES NOT BELIEVE THAT THE TRIMLINE BP CUFF MALFUNCTIONED OR CAUSED OR CONTRIBUTED TO THE ALLEGED INJURY. THE BP MONITOR IS RESPONSIBLE FOR THE INFLATION OF THE CUFF AND OCCLUSION OF THE BLOOD FLOW. THE BP CUFF ITSELF IS A PASSIVE DEVICE. WE ARE FILING THIS REPORT IN AN ABUNDANCE OF CAUTION. METHOD CODE: OTHER (DEVICE NOT RETURNED FOR EVAL). CONCLUSION: (UNABLE TO CONFIRM ALLEGATION).

    Description of Event or Problem · 1

    PER THE MEDWATCH (B)(4) RECEIVED AT WELCH ALLYN, A (B)(6) MALE WITH HISTORY OF DIABETES, OBESITY, AND HIGH BLOOD PRESSURE SUSTAINED A LEFT ARM INJURY DURING A 6 HOUR SURGERY. THE PROCEDURE WAS UNDER GENERAL ANAESTHESIA. THE PT'S LEFT ARM WAS SWOLLEN, RED, AND PAINFUL, AND WITH DECREASED MOBILITY, AND NUMBNESS. THE INJURY WAS IDENTIFIED POST SURGERY, AND AS SUCH THE BLOOD PRESSURE CUFF HAD ALREADY BEEN DISCARDED. AS OF (B)(6) THE PT CONTINUED WITH RESIDUAL NUMBNESS AND DECREASED LEFT ARM USE AND WAS BEGINNING OCCUPATIONAL THERAPY. THE CUSTOMER DID NOT PROVIDE A PT IDENTIFIER. REF UF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158123 TRIMLINE DISPOSABLE BLOOD PRESSURE CUFF DXQ WELCH ALLYN, INC. CUFF TL DISP, SOFT, A UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention