BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 169700 · Received May 22, 1998

    Report

    Report Number
    2248146-1998-00577
    Event Type
    Malfunction
    Date Received
    May 22, 1998
    Report Date
    May 19, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 06/08/1998). EVALUATION: LABORATORY EXAMINATION OF THE RETURNED ITEM REVEALED NO DEFECT. UNDERWATER LEAK TESTING REVEALED NO LEAKS IN THE IAB. TESTING FOR OCCULT BLOOD WITHIN THE BALLOON WAS NEGATIVE. THE IAB INFLATED & FUNCTIONED NORMALLY WHEN ATTACHED TO THE SYSTEM 97 IABP IN THE LAB. NO ALARMS WERE TRIGGERED. PROBABLE CUASE OF DIFFICULTY: NO LEAK WAS FOUND IN THE RETURNED IAB. IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED DIFFICULTY BASED ON THE EVENT DESCRIPTION AND EXAMINIATION OF THE RETURNED PRODUCT.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DATASCOPE ON 06/08/1998: THE IAB APPEARED TO BE LEAKING. THE BALLOON WAS REMOVED AND ANOTHER WAS INSERTED. THE DOCTOR INDICATED THAT THERE WAS NO HARM TO THE PT AS A RESULT OF THE EVENT. (EVENT COMPLICATIONS): NONE FROM THE EVENT - REPORTED 05/19/1998 AND 06/08/1998. (PT'S CURRENT STATUS): UNK - REPORTED 05/19/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 40 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0306 03/01/00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN