BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNMED LLC

    MDR report key: 7980434 · Received October 18, 2018

    Report

    Report Number
    1314417-2018-00043
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    September 20, 2018
    Report Date
    October 18, 2018
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    BTM
    UDI-DI
    10889483103012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    "THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY PER FDA REQUEST". CUSTOMER COMPLAINT WAS CONFIRMED. AFFECTED DEVICES WERE RETURNED FOR EVALUATION. TWENTY-THREE OF THE REPORTED TWENTY-FOUR MASKS WERE DEEMED TO BE NON-CONFORMING. A CORRECTIVE ACTION PREVENTATIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE. WE APOLOGIZE FOR ANY INCONVENIENCE THIS MAY HAVE CAUSED AND APPRECIATE YOU CONTACTING US REGARDING THIS INCIDENT AS WE CONTINUALLY MONITOR AND ANALYZE COMPLAINTS DATA AS PART OF OUR CONTINUOUS IMPROVEMENT EFFORTS. ONLY THE MASKS WERE SENT, NO RESUSCITATOR BAGS. SAMPLES WERE NOT LABELLED WHICH LOT THEY WERE FROM, BUT THE REMOVED POLYBAGS WERE INCLUDED. ONLY 23 MASKS INCLUDED, WITH VARYING LEVELS OF MASK PORT DEFORMATION, FROM MINOR TO SEVERE. THE ORIGINAL AFFECTED LOT FROM THE CUSTOMER WAS 313909. REPLACEMENT MATERIAL WAS SENT FROM DISTRIBUTOR IN ARLINGTON TX TO THE CUSTOMER AND THE ADDITIONAL 5 LOT NUMBERS OF EFFECTED DEVICES WERE FOUND IN THE REPLACEMENT MATERIAL. ALL MASKS ARE 100% INSPECTED BEFORE PACKAGING WITH THE RESUSCITATION BAG. RATES OF RAW MASK MATERIAL PORT ROUNDNESS ARE NOTED BELOW. 313909: 0/1500 MASK PORT OUT OF ROUNDNESS, NO PRODUCT REPLACED. 315059: 40/1500 MASK PORT OUT OF ROUNDNESS, ALL PRODUCT REJECTED REPLACED WITH CONFORMING MATERIAL 312282: 33/1500 MASK PORT OUT OF ROUNDNESS, ALL PRODUCT REJECTED REPLACED WITH CONFORMING MATERIAL 314649: 31/1500 MASK PORT OUT OF ROUNDNESS, ALL PRODUCT REJECTED REPLACED WITH CONFORMING MATERIAL 314795: 60/1500 MASK PORT OUT OF ROUNDNESS, ALL PRODUCT REJECTED REPLACED WITH CONFORMING MATERIAL 313061: 25/1500 MASK PORT OUT OF ROUNDNESS, ALL PRODUCT REJECTED REPLACED WITH CONFORMING MATERIAL. PRODUCT RETURNED FROM CUSTOMER WAS TESTED ON A SAMPLE PATIENT PORT AND 5/23 MASK PORTS WERE UNABLE TO FIT ONTO THE PATIENT PORT. THE REST OF THE PARTS WERE ABLE TO FIT ONTO THE PATIENT PORT WITH LIGHT TO MODERATE FORCE.

    Additional Manufacturer Narrative · 0

    "THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY PER FDA REQUEST". CUSTOMER COMPLAINT WAS CONFIRMED. AFFECTED DEVICES WERE RETURNED FOR EVALUATION. TWENTY-THREE OF THE REPORTED TWENTY-FOUR MASKS WERE DEEMED TO BE NON-CONFORMING. A CORRECTIVE ACTION PREVENTATIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE. WE APOLOGIZE FOR ANY INCONVENIENCE THIS MAY HAVE CAUSED AND APPRECIATE YOU CONTACTING US REGARDING THIS INCIDENT AS WE CONTINUALLY MONITOR AND ANALYZE COMPLAINTS DATA AS PART OF OUR CONTINUOUS IMPROVEMENT EFFORTS. ONLY THE MASKS WERE SENT, NO RESUSCITATOR BAGS. SAMPLES WERE NOT LABELLED WHICH LOT THEY WERE FROM, BUT THE REMOVED POLYBAGS WERE INCLUDED. ONLY 23 MASKS INCLUDED, WITH VARYING LEVELS OF MASK PORT DEFORMATION, FROM MINOR TO SEVERE. THE ORIGINAL AFFECTED LOT FROM THE CUSTOMER WAS 313909. REPLACEMENT MATERIAL WAS SENT FROM DISTRIBUTOR IN ARLINGTON TX TO THE CUSTOMER AND THE ADDITIONAL 5 LOT NUMBERS OF EFFECTED DEVICES WERE FOUND IN THE REPLACEMENT MATERIAL. ALL MASKS ARE 100% INSPECTED BEFORE PACKAGING WITH THE RESUSCITATION BAG. RATES OF RAW MASK MATERIAL PORT ROUNDNESS ARE NOTED BELOW. 313909: 0/1500 MASK PORT OUT OF ROUNDNESS, NO PRODUCT REPLACED 315059: 40/1500 MASK PORT OUT OF ROUNDNESS, ALL PRODUCT REJECTED REPLACED WITH CONFORMING MATERIAL 312282: 33/1500 MASK PORT OUT OF ROUNDNESS, ALL PRODUCT REJECTED REPLACED WITH CONFORMING MATERIAL 314649: 31/1500 MASK PORT OUT OF ROUNDNESS, ALL PRODUCT REJECTED REPLACED WITH CONFORMING MATERIAL 314795: 60/1500 MASK PORT OUT OF ROUNDNESS, ALL PRODUCT REJECTED REPLACED WITH CONFORMING MATERIAL 313061: 25/1500 MASK PORT OUT OF ROUNDNESS, ALL PRODUCT REJECTED REPLACED WITH CONFORMING MATERIAL PRODUCT RETURNED FROM CUSTOMER WAS TESTED ON A SAMPLE PATIENT PORT AND 5/23 MASK PORTS WERE UNABLE TO FIT ONTO THE PATIENT PORT. THE REST OF THE PARTS WERE ABLE TO FIT ONTO THE PATIENT PORT WITH LIGHT TO MODERATE FORCE.

    Description of Event or Problem · 0

    CUSTOMER STATES THAT MASKS ON RESUS BAGS ARE WARPED.

    Description of Event or Problem · 0

    CUSTOMER STATES THAT MASKS ON RESUS BAGS ARE WARPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823249 SUNMED LLC SMALL ADULT AIRFLOW W/MANOMETER BTM SUNMED HOLDINGS LLC AF5140MB 10889483103012

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other