BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ER920W EVENT RECORDER

    MDR report key: 3040246 · Received April 3, 2013

    Report

    Report Number
    2133409-2013-00001
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BRAEMAR
    Product Code
    DRG
    PMA / PMN Number
    K072008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BRAEMAR HAS MADE SEVERAL REQUESTS FOR ADDITIONAL INFORMATION REGARDING THE PATIENT STATUS, THE EVENT, AND THE DEVICE. BASED ON THE INITIAL REPORT, THE COMPANY UNDERSTANDS THAT THE PATIENT WAS SEEN IN AN EMERGENCY ROOM FOLLOWING THE EVENT. THE DISTRIBUTOR HAS REACHED OUT TO THE PATIENT AND HER FAMILY TO REQUEST ADDITIONAL DETAIL REGARDING THE EVENT, BUT HAS RECEIVED VERY LIMITED DETAIL. THE COMPANY HAS NOT BEEN PROVIDED WITH CONFIRMATION THAT THE PATIENT WAS INJURED AND IF SO, THE NATURE AND SERIOUSNESS OF THE INJURY, IF AN INJURY OCCURRED. THE COMPANY HAS ALSO NOT BEEN PROVIDED WITH ANY DETAIL REGARDING TREATMENT RECEIVED AT THE EMERGENCY ROOM OR THE SPECIFIC REASON SHE WENT THERE. BRAEMAR IS NOT AWARE OF ANY HOSPITALIZATION THE PATIENT MAY HAVE UNDERGONE. BASED ON FOLLOW-UP BY THE DISTRIBUTOR, BRAEMAR HAS BEEN INFORMED THAT THE PATIENT INDICATED THAT "SHE IS HEALING". UNTIL BRAEMAR RECEIVES ADDITIONAL CLARIFYING INFORMATION, IT IS TREATING THIS POTENTIAL EVENT AS REPORTABLE BASED ON THE COMMUNICATION FROM THE DISTRIBUTOR THAT THE PATIENT WAS SEEN AT THE EMERGENCY ROOM. BRAEMAR HAS REQUESTED THAT THE DEVICE AND ACCESSORIES BE RETURNED SO THAT ANALYSIS CAN BE PERFORMED. THE DISTRIBUTOR HAS REQUESTED ON BEHALF OF THE COMPANY THAT THE PATIENT RETURN THE DEVICE. AT THIS TIME, THE DEVICE AND ASSOCIATED ACCESSORIES HAVE NOT BEEN RETURNED. AS SUCH, BRAEMAR IS NOT ABLE TO DETERMINE WHETHER THE DEVICE OR ITS ACCESSORIES COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, BRAEMAR IS UNABLE TO CONFIRM THE EVENT OR DETERMINE ROOT CAUSE. BASED ON THE INITIAL REPORT THAT THE DEVICE "EXPLODED", BRAEMAR IS REPORTING THIS EVENT AS A REPORTABLE MALFUNCTION UNTIL RECEIVES ADDITIONAL CLARIFYING INFORMATION. BRAEMAR HAS BEEN INFORMED BY THE DISTRIBUTOR THAT IT HAS DISTRIBUTED BATTERIES THAT WERE NOT RECOMMENDED BY THE MFR, CONTRARY TO THE LABELING. BRAEMAR IS UNABLE TO DETERMINE, AT THIS TIME, WHETHER THE INSTALLATION OF NON-MANUFACTURER RECOMMENDED BATTERIES CAUSED OR CONTRIBUTED TO THE EVENT. THE USER'S MANUAL FOR ER920W EVENT RECORDER CAUTIONS, "CAUTION: ONLY USE A BRAEMAR SUPPLIED 3.6 V LITHIUM THIONYL BATTERY PACK. DO NOT USE ANY OTHER BATTERY IN THE ER920W. USE OF ANY OTHER BATTERY PACK OR MIXING BATTERIES MAY CAUSE OVERHEATING AND/ OR DAMAGE THE DEVICE." BECAUSE BRAEMAR HAS NOT BEEN PROVIDED WITH ADDITIONAL DETAIL REGARDING THE EVENT, INFORMATION REGARDING THE PATIENT'S STATUS, OR THE DEVICE FOR ANALYSIS, THE COMPANY IS UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT OR THE DEGREE TO WHICH THE DEVICE OR ITS ACCESSORIES MAY HAVE CONTRIBUTED TO THE EVENT, IF ANY. ALTHOUGH IT IS UNKNOWN IF THE DEVICE OR ITS ACCESSORIES CONTRIBUTED TO THE REPORTED EVENT, THE COMPANY IF FILING THIS MEDWATCH FORM FOR NOTIFICATION PURPOSES. THIS DEVICE IS INTENDED FOR REUSE. AT THIS POINT, IT IS UNKNOWN WHETHER REUSE PLAYED A ROLE IN THE REPORTED EVENT.

    Description of Event or Problem · 1

    BRAEMAR RECEIVED INFORMATION ON (B)(6) 2013, FROM (B)(4) IN WHICH THEY REPORTED A POTENTIAL ADVERSE INCIDENT INVOLVING ONE OF THE BRAEMAR ER920W EVENT RECORDERS. ON (B)(6) 2013 (B)(4) RECEIVED A PHONE CALL FROM A PATIENT'S HUSBAND WHO TOLD THEM HIS WIFE WAS WEARING AN ER920W MONITOR THAT "EXPLODED" WHILE SHE WAS WEARING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135590 ER920W EVENT RECORDER DRG, MLO DRG BRAEMAR ER920W

    Patients

    Seq Age Sex Outcome Treatment
    1