BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

    MDR report key: 16121495 · Received January 9, 2023

    Report

    Report Number
    2518422-2023-01046
    Event Type
    Malfunction
    Date Received
    January 9, 2023
    Date of Event
    December 19, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    BZD
    Removal / Correction Number
    RES90705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MASK IS INTENDED TO PROVIDE AN INTERFACE FOR APPLICATION OF CPAP OR BI-LEVEL THERAPY TO PATIENTS. THE MASK IS FOR SINGLE PATIENT USE IN THE HOME OR MULTI-PATIENT USE IN THE HOSPITAL/INSTITUTIONAL ENVIRONMENT. THE MASK IS TO BE USED ON PATIENTS (>66LBS/30KG) FOR WHOM CPAP OR BI-LEVEL THERAPY HAS BEEN PRESCRIBED. THE USER IS WARNED, "CONSULT A PHYSICIAN OR DENTIST IF YOU ENCOUNTER TOOTH, GUM, OR JAW SORENESS. USE OF A MASK MAY AGGRAVATE AN EXISTING DENTAL CONDITION." THE MASK INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING WARNINGS: THE MASK ASSEMBLY CONTAINS MAGNETS. SOME MEDICAL DEVICES MAY BE AFFECTED BY MAGNETIC FIELDS. THE MAGNETIC CLIPS IN THIS MASK SHOULD BE KEPT AT LEAST 6 INCHES (APPROX.15.24 CM) AWAY FROM ANY ACTIVE MEDICAL DEVICE WITH SPECIAL ATTENTION TO IMPLANTED DEVICES SUCH AS PACEMAKERS, DEFIBRILLATORS AND COCHLEAR IMPLANTS. DO NOT USE IN OR NEAR MAGNETIC RESONANCE IMAGING (MRI) EQUIPMENT. KEEP UNASSEMBLED MAGNETIC HEADGEAR CLIPS OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL SWALLOWING, SEEK MEDICAL ASSISTANCE IMMEDIATELY. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT AN END USER HAS METAL BARS BEHIND THE TOP AND BOTTOM OF THEIR FRONT TEETH AND THE TEETH STARTED SHIFTING 2.5 YEARS AGO WHILE USING A PHILIPS MAGNETIC MASK. THE USER ALLEGES SHE HAD THE METAL BARS PLACED TO KEEP TEETH ALIGNED AFTER HAVING BRACES 30 YEARS AGO. THE USER ALLEGES HER TEETH ARE OUT OF LINE, CROOKED, SHE CANNOT FLOSS IN BETWEEN THEM, AND SHE HAS HEADACHES. THE USER STATES SHE PURCHASED A NEW MOUTH GUARD WHICH IS HELPING, BUT SHE IS STILL IN PAIN. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. ATTEMPTS TO OBTAIN MORE INFORMATION ABOUT WHICH PHILIP'S MASK THE PATIENT WAS USING WERE UNSUCCESSFUL. NO PRODUCT WILL BE RETURNED FOR INVESTIGATION. THE USER STOPPED USING THE MASK ON 12/17/2022. THE MANUFACTURER SUGGESTED USING ANOTHER MASK WITHOUT MAGNETIC CLIPS. THE MANUFACTURER WILL CONTINUE TO MONITOR COMPLAINTS FOR SIMILAR ISSUES. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NEEDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2301469 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS NORTH AMERICA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female