BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PH CAPSULE

    MDR report key: 21759613 · Received April 3, 2025

    Report

    Report Number
    3011219572-2025-00001
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    February 20, 2025
    Report Date
    April 3, 2025
    Manufacturer
    CHONGQING JINSHAN SCIENCE & TECHNOLOGY (GROUP) CO.
    Product Code
    FFT
    UDI-DI
    06946332800045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    JINSHAN EVALUATED THE EVENT BASED ON ALL INFORMATION RECEIVED. THE PH CAPSULE WAS NOT RETURNED. TESTING OF PRODUCTS FROM THE SAME BATCH CONFIRMED COMPLIANCE WITH THE SPECIFIED REQUIREMENTS. THE DEVICE HISTORY RECORD (DHR) FOR THIS BATCH WAS REVIEWED AND FOUND TO COMPLY WITH THE DEVICE MASTER RECORD (DMR). A REVIEW OF COMPLAINTS OVER THE PAST THREE YEARS REVEALED NO INCIDENTS OF PH CAPSULES ENTERING THE TRACHEA. BASED ON THE AVAILABLE INFORMATION, NO CAUSE FOR THE PRODUCT MALFUNCTION COULD BE IDENTIFIED. THIS REPORT IS SUBMITTED IN COMPLIANCE WITH FDA REGULATIONS 21 CFR PARTS 803. JINSHAN HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE AS OF THE SUBMISSION DATE OF THIS REPORT. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION OF JINSHAN, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT IS REPORTED THAT UPON PLACING THE PH CAPSULE, THE PROBE DISLODGED IN THE POSTERIOR OROPHARYNX REGION AND WAS SITTING ON THE VOCAL CORDS. AS THE MD ATTEMPTED TO GRAB THE PROBE WITH BIOPSY FORCEPS, THE PROBE ADVANCED INTO THE TRACHEA. PATIENT WAS STABILIZED AND INTUBATED. EMS CALLED IMMEDIATELY, ED NOTIFIED. PH CAPSULE WAS REMOVED BY SGR HOSPITAL. PT WAS THEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846812 PH CAPSULE PH CAPSULE FFT CHONGQING JINSHAN SCIENCE & TECHNOLOGY (GROUP) CO. JSPC-1 JSPC0985002 06946332800045

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention MEDELA VARIO 18 SUCTION PUMP.