BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON FOLDABLE MANUAL RESUS,DISP, ADULT W/FLO

    MDR report key: 5116486 · Received October 1, 2015

    Report

    Report Number
    1044475-2015-00373
    Event Type
    Malfunction
    Date Received
    October 1, 2015
    Date of Event
    July 14, 2015
    Report Date
    September 18, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDWATCH # 2211900000-2015-8004. (B)(4). THE INVESTIGATION RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION. A DHR REVIEW WAS PERFORMED ON THE LOT NUMBER AND NO ISSUES WERE FOUND THAT COULD RELATE TO THE REPORTED ISSUE. THE PRODUCT WAS MANUFACTURED IN 2010 AND IT WAS OUT OF THE EXPIRATION DATE IN 2013. SIMILAR COMPLAINTS HAVE BEEN RECEIVED WITH THE DEFLATED MASK ISSUE AND IT WAS DETERMINED THAT THE AIR LEAKED NATURALLY DURING THE LONG TIME IN STORAGE AND/OR TRANSPORTATION. THE CUSHION ON THE MASK IS MADE OF PVC AND DURING A LONG TIME IN STORAGE THE AIR IN THE CUSHION WILL LEAK NATURALLY.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED VIA MEDWATCH. THE CUSTOMER ALLEGES THAT AN ELDERLY MALE (ASA 3) UNDERWENT AN UPPER ENDOSCOPY. THE PATIENT RECEIVED VERSED, PROPOFOL AND FENTANYL. HE OBSTRUCTED AND BECAME UNRESPONSIVE AND OXYGEN SATURATION FELL TO 25%. A MANUAL RESUSCITATOR WAS APPLIED AND ORAL AIRWAY INSERTED. THE AIR CUSHION ON THE MASK WAS FOUND DEFLATED RENDERING VENTILATION IN EFFECTIVE. ANOTHER RESUSCITATOR WAS OBTAINED AND PATIENT SUCCESSFULLY VENTILATED. THE PATIENT DEVELOPED BRADYCARDIA AND WAS RESOLVED WITH MEDICATION. THE PATIENT WOKE UP NEUROLOGICALLY INTACT, EKG UNCHANGED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED VIA MEDWATCH. THE CUSTOMER ALLEGES THAT AN ELDERLY MALE (ASA 3) UNDERWENT AN UPPER ENDOSCOPY. THE PATIENT RECEIVED VERSED, PROPOFOL AND FENTANYL. HE OBSTRUCTED AND BECAME UNRESPONSIVE AND OXYGEN SATURATION FELL TO 25%. A MANUAL RESUSCITATOR WAS APPLIED AND ORAL AIRWAY INSERTED. THE AIR CUSHION ON THE MASK WAS FOUND DEFLATED RENDERING VENTILATION INEFFECTIVE. ANOTHER RESUSCITATOR WAS OBTAINED AND PATIENT SUCCESSFULLY VENTILATED. THE PATIENT DEVELOPED BRADYCARDIA AND WAS RESOLVED WITH MEDICATION. THE PATIENT WOKE UP NEUROLOGICALLY INTACT, EKG UNCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650235 HUDSON FOLDABLE MANUAL RESUS,DISP, ADULT W/FLO MANUAL RESUSCITATOR BTM TELEFLEX MEDICAL 1033

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention