BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMARA VIEW

    MDR report key: 22460382 · Received July 9, 2025

    Report

    Report Number
    2518422-2025-107196
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    July 7, 2025
    Report Date
    December 19, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959009219
    PMA / PMN Number
    K082866
    Removal / Correction Number
    Z-1783-2022.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE HHE - PATIENT INTERFACE MAGNET HHE ER 2242274 PAGE 15 SECTION 3: HEALTH RISKS STATES, "ALL MAGNET MASKS CONTAINED A WARNING AGAINST HAVING THE MAGNET MASK WITHIN 2 INCHES OF ANY ACTIVE MEDICAL IMPLANT OR MEDICAL DEVICE THAT CAN BE IMPACTED BY THE MAGNETIC FIELD."

    Additional Manufacturer Narrative · 0

    THE PRODUCT ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED TO THE MANUFACTURER. THIS REPORT IS BEING SENT TO CONCLUDE THAT NO FURTHER INVESTIGATION IS POSSIBLE. NO DEVICE HAS BEEN RETURNED. NO FURTHER EVALUATION IS POSSIBLE AT THIS TIME. DESPITE THREE GOOD FAITH-EFFORT ATTEMPTS ON (07/22/2025), (07/25/2025), AND (08/07/2025) TO +1(832)283-7991 TO HAVE THE DEVICE RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. SECTION IN BOX H HAS BEEN UPDATED/CORRECTED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION FROM THE PATIENT WITH ALLEGATION OF CHEST PAIN WHILE USING HIS AMARA VIEW MASK MAGNET. PATIENT STATED WHILE HE WAS ASLEEP, HE STARTED HAVING CHEST PAIN, WITH HIS NECK ON HIS SHOULDERS. THE PATIENT DID NOT SEEK MEDICAL INTERVENTION THE NEXT DAY, BUT HAD PRIOR TO, AND THE DOCTOR STATED THE MASK MAGNETS HAD INTERFERE WITH HIS STINTS. THE PATIENT ALLEGES THAT HE IS SLUGGISH AND TIRED BECAUSE OF THE CHEST PAIN. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169077 AMARA VIEW VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 1090624 00606959009219

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male