BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE ALTA

    MDR report key: 25333050 · Received May 29, 2026

    Report

    Report Number
    2015691-2026-15640
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 29, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQE
    UDI-DI
    00690103217964
    PMA / PMN Number
    K232294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODES INCLUDE DSB PLETHYSMOGRAPH, IMPEDANCE. DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE. FLL THERMOMETER, ELECTRONIC, CLINICAL. MUD OXIMETER, TISSUE SATURATION. QAQ ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR. QEM CEREBRAL OXIMETER. QMS ADJUNCTIVE OPEN LOOP FLUID THERAPY RECOMMENDER. QNL MEDIUM-TERM ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR. DQK COMPUTER, DIAGNOSTIC, PROGRAMMABLE. THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

    Description of Event or Problem · 0

    AS REPORTED DURING USE THE ALTA MONITOR DISPLAYED INACCURATE VALUES. THE SYSTOLIC AND DIASTOLIC PRESSURE VALUES WERE 20-30 POINTS OFF FROM ANOTHER MEASUREMENT DEVICE. IT IS UNKNOWN WHAT THE OTHER MEASUREMENT DEVICE WAS. THERE WERE NO ERROR MESSAGES OR AN ABNORMAL WAVEFORM. WHEN DEVICES WERE CONNECTED TO A DIFFERENT ALTA MONITOR, THIS ISSUE DID NOT OCCUR. THERE WAS NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622510 HEMOSPHERE ALTA CATHETER, OXIMETER, FIBER-OPTIC DQE EDWARDS LIFESCIENCES ALTASR1 00690103217964

    Patients

    Seq Age Sex Outcome Treatment
    1