BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUEST INFUSOR

    MDR report key: 9370 · Received July 12, 1993

    Report

    Report Number
    9370
    Event Type
    Malfunction
    Date Received
    July 12, 1993
    Date of Event
    April 3, 1993
    Report Date
    June 28, 1993
    Manufacturer
    KENDALL MCGAW LABORATORY
    Product Code
    KZD
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE INFUSOR OVER INFUSED NITROGLYCERIN INTO THE PATIENT. EXAMINATION REVEALED NO ADVERSE EFFECTS AND/OR INJURY TO THE PATIENT. PRODUCT RETURNED TO THE MANUFACTURER FOR EVALUATION ON APRIL 13, 1993.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUEST INFUSOR INFUSOR KZD KENDALL MCGAW LABORATORY QUEST 2001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other