BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIMETER

    MDR report key: 176618 · Received July 8, 1998

    Report

    Report Number
    176618
    Event Type
    Malfunction
    Date Received
    July 8, 1998
    Date of Event
    April 26, 1998
    Report Date
    June 26, 1998
    Manufacturer
    TIMETER INSTRUMENT CORP.
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OXYGEN REGULATOR MALFUNCTION; BREATH SOUNDS (ANTERIORLY) WITH SMALL AMOUNT OF RHONCHI. PT STATES SHE HAS NO CHEST DISCOMFORT. RESPIRATORY THERAPY PAGED AND CHECKED EQUIPMENT AND PT. PT SATS WERE AT 97%. UNFORTUNATELY, FACILITY CANNOT IDENTIFY THE PARTICULAR UNIT WHICH WAS AFFECTED. HOWEVER, RPTR IS TOLD BY BIOMED PERSONNEL THAT IF THE UNIT WAS MALFUNCTIONING IT WOULD HAVE BEEN REPLACED AND NOT REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIMETER OXYGEN REGULATOR CAN TIMETER INSTRUMENT CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other