BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADULT MPR W/ ADULT MASK, AND RESERVOIR BAG

    MDR report key: 2346717 · Received November 16, 2011

    Report

    Report Number
    9680866-2011-00001
    Event Type
    Death
    Date Received
    November 16, 2011
    Date of Event
    September 9, 2011
    Report Date
    October 17, 2011
    Manufacturer
    UNOMEDICAL S.A. DE C.V.
    Product Code
    BTM
    PMA / PMN Number
    K873286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IN F/U WITH (B)(6), "THE PERSON OPERATING THE AMBUBAG NOTICED THAT THE AMBUBAG FAILED TO DELIVER OXYGEN, EVEN UPON REPOSITIONING THE PATIENT'S HEAD. THE AMBUBAG WAS THEN IDENTIFIED AS MALFUNCTIONING AND WITHIN 30 SECONDS, THE PATIENT WAS BEING OXYGENATED WITH ANOTHER COMPANY'S AMBUBAG. THE PATIENT NEVER RECOVERED FROM THE ARREST AND WAS PRONOUNCED DEAD IN THE HOSPITAL." BASED ON THE DETAILS PROVIDED IT IS HIGHLY UNLIKELY THAT THE 30-SECOND DELAY DUE TO PRODUCT MALFUNCTION WOULD HAVE CAUSED OR CONTRIBUTED TO THE FATAL OUTCOME. HOWEVER, WE CANNOT COMPLETELY RULE OUT THAT THE MALFUNCTION DID NOT CONTRIBUTE TO THE DEATH AND AS SUCH WE RECOMMEND TO REPORT THIS AS A FATAL OUTCOME. REPORTED TO THE FDA ON (B)(4) 2011. NOTE: THIS PRODUCT WAS FROM A LOT OF PREVIOUSLY RECALLED DEVICES. THE FOLLOWING IS A SUMMARY OF THE ACTIONS INVOLVED IN THAT RECALL, CLOSED IN (B)(6) 2010: MPR MARKET ACTION HISTORY - (B)(4). CONSISTENT WITH OUR RECALL PROCESS, THE FOLLOWING ACTIONS WERE COMPLETED FOR THE MANUAL PULMONARY RESUSCITATORS RECALL SPECIFIC TO (B)(4): ACTION DATE(S): DECISION MADE TO RECALL MANUAL PULMONARY RESUSCITATORS (MPRS) (B)(4) 2009. FDA NOTIFIED OF DECISION TO RECALL MPRS (B)(4) 2009. PRESS RELEASE PUBLISHED (B)(4) 2009. FIRST CUSTOMER LETTER SENT TO (B)(4), (B)(4) 2009. (B)(4). RECALL TRACKING NUMBER ASSIGNED BY FDA (B)(4) 2009. SECOND CUSTOMER LETTER SENT TO (B)(4), (B)(4) 2009. THIRD CUSTOMER LETTER SENT TO (B)(4), (B)(4) 2009. FOUR MONTHLY FDA STATUS UPDATES SENT TO FDA: (B)(4) 2009, (B)(4) 2009, (B)(4) 2010, AND (B)(4) 2010. DESTRUCTION OF RECALLED MPRS (B)(4) AND (B)(4) 2010. FINAL FDA STATUS UPDATE SENT TO FDA (B)(4) 2010. RECEIVED CLOSE OUT LETTER FROM FDA (B)(4) 2010. MEDWATCH REPORT RECEIVED ((B)(4)) (B)(4) 2011. CONTACTED MEDWATCH REPORTER TO ASCERTAIN STATUS OF MPR INVENTORY. (B)(4) 2011.

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT ON MEDWATCH UF/IMPORTER NUMBER (B)(4) AS FOLLOWS: ON THE FIRST TREATMENT THE PATIENT HAD A RESPIRATORY ARREST WITHIN 15 MINUTES OF TREATMENT START. BLOOD PRESSURE AND PULSE NOTED WITH NO RESPIRATIONS. AMBU BAGGING INITIATED USING BLUE COLORED UNOMEDICAL INC. AMBU BAG LOT 04-40 DISTRIBUTED BY (B)(4). THE AMBU BAG FAILED TO PROVIDE POSITIVE PRESSURE VENTILATION AND WAS IMMEDIATELY REPLACED WITH ANOTHER AMBU BAG FROM A DIFFERENT COMPANY UNTIL EMS ARRIVED IN FIVE MINUTES. PATIENT TRANSPORTED BY EMS TO LOCAL HOSPITAL WHERE SHE EXPIRED. THE EVENT IS DEEMED SERIOUS BECAUSE THE EVENTUAL OUTCOME FOR THE PATIENT WAS DEATH. FROM A CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THIS EVENT IS DEEMED POSSIBLE BECAUSE IT WAS REPORTED TO BE INEFFECTIVE AT PROVIDING RESPIRATORY AIR TO (B)(6) PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT MPR W/ ADULT MASK, AND RESERVOIR BAG VENTILATOR, EMERG. MANUAL (RESUSCITATOR) BTM UNOMEDICAL S.A. DE C.V. UNK 04-40

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death