BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 34 CC. IAB

    MDR report key: 171620 · Received June 4, 1998

    Report

    Report Number
    2248146-1998-00610
    Event Type
    Malfunction
    Date Received
    June 4, 1998
    Date of Event
    June 2, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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 AND FUNCTIONED NORMALLY WHEN ATTACHED TO THE SYSTEM 97 IABP IN THE LAB. NO ALARMS WERE TRIGGERED. PROBABLE CAUSE OF DIFFICULTY: NO LEAK WAS FOUND IN THE RETURNDED IAB. IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED DIFFICULTY BASED ON THE EVENT DESCRIPTION AND EXAMINATION OF THE RETURNED PRODUCT. (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 7/17/98)

    Description of Event or Problem · 1

    (CC# 98-00645) THE IAB LEAKED. THIS WAS THE ONLY INFORMATION AT THE TIME OF THE REPORT. ON 6/25/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: BLOOD WAS NOTED IN THE CATHETER TUBING AND THE IABP WAS ALARMING. THE IAB WAS REMOVED AND ANOTHER WAS INSERTED. THERE WAS NO PT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. IT WAS REPORTED THAT THE PT DID EXPIRE ON 6/2/98 AT 9:08 PM. (MULTIPLE EVENT TO CUSTOMER COMPLAINT 98-00803). EVENT COMPLICATIONS: UNK - REPORTED 5/28/98; NONE - REPORTED 6/25/98. PATIENT'S CURRENT STATUS: EXPIRED - REPORTED 6/25/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 34 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0206-01 03/09/00

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR