BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUNMED LLC

    MDR report key: 19038189 · Received April 3, 2024

    Report

    Report Number
    1314417-2024-00017
    Event Type
    Death
    Date Received
    April 3, 2024
    Date of Event
    March 4, 2024
    Report Date
    April 3, 2024
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    NHK
    UDI-DI
    10889483090237
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT EXPIRED DURING THE USE OF THE DEVICE, EVEN THOUGH THE CLINICIAN INDICATES THAT THE DEVICE WAS NOT THE CAUSE FOR THE PATIENT TO EXPIRE. FURTHER COMMUNICATION WITH COMPLAINTANT INDICATED THAT THERE WAS NO INJURY/DEATH INVOLVED WITH THE USE OF THIS DEVICE. THE COMPLAINT OF "TUBE THAT GOES TO THE BACK EXHAUST TEETH IN IS NOT CONNECTED" REGARDING PART NUMBER AF2142MB WAS NOT ABLE TO BE CONFIRMED DUE TO A LACK OF IMAGES OR RETURNED PRODUCT. THE ROOT CAUSE WAS NOT CONFIRMED BUT THE AFFECTED DEVICE WAS MANUFACTURED IN 2013 AND THEREFORE WAS SIGNIFICANTLY PAST ITS STATED SHELF LIFE OF 5 YEARS, WHICH COULD HAVE LEAD TO DEGRADED FUNCTION. A RISK ASSESSMENT WAS PERFORMED AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE INITIATION OF A CAPA. THERE HAVE BEEN ZERO OTHER COMPLAINTS REGARDING THE SAME PART FAMILY AND A SIMILAR ISSUE IN THE 24 MONTHS PRECEDING THIS REPORTED EVENT. A RESOLUTION EMAIL WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.

    Additional Manufacturer Narrative · 0

    THE PATIENT EXPIRED DURING THE USE OF THE DEVICE, EVEN THOUGH THE CLINICIAN INDICATES THAT THE DEVICE WAS NOT THE CAUSE FOR THE PATIENT TO EXPIRE. FURTHER COMMUNICATION WITH COMPLAINTANT INDICATED THAT THERE WAS NO INJURY/DEATH INVOLVED WITH THE USE OF THIS DEVICE.

    Description of Event or Problem · 0

    PRODUCT COMPLAINT # (B)(4) REGARDING OUR ITEM # 87-AF2142MBEA- RESUS, PED, AIRFL, MAN, POP-OFF (SUNMED # AF2142MB). OUR CUSTOMER, STEPHANIE EDWARDS, HAS REPORTED "AMBU BAGS / TAPED TO BACK / O2 TUBE THRU INSIDE COMES OUT END HOOK TO O2 SOURCE / TUBE THT GOES TO BACK/EXHAST TEETHIN IS NOT CONNECTED TUBE IS COMING OUT. CUSTOMER STATES THE PAITENT DID EXPIRE BUT DID NOT FEEL BECAUSE OF THIS . THEY HAD TO USE 4 BAGS DUE TO TUBE COMING OUT." PER THE CONVERSATION WITH PRODUCT QUALITY, NO INJURY/DEATH WAS INVOLVED - (B)(6) (COMPLAINTANT).

    Description of Event or Problem · 0

    PRODUCT COMPLAINT # (B)(4) REGARDING OUR ITEM # 87-AF2142MBEA- RESUS, PED, AIRFL, MAN, POP-OFF (SUNMED # (B)(4)). OUR CUSTOMER, STEPHANIE EDWARDS, HAS REPORTED "AMBU BAGS / TAPED TO BACK / O2 TUBE THRU INSIDE COMES OUT END HOOK TO O2 SOURCE / TUBE THT GOES TO BACK/EXHAST TEETHIN IS NOT CONNECTED TUBE IS COMING OUT.CUSTOMER STATES THE PATIENT DID EXPIRE BUT DID NOT FEEL BECAUSE OF THIS . THEY HAD TO USE 4 BAGS DUE TO TUBE COMING OUT." PER THE CONVERSATION WITH PRODUCT QUALITY, NO INJURY/DEATH WAS INVOLVED - STEPHANIE EDWARDS (COMPLAINANT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729683 SUNMED LLC PEDI W/MANOMETER & POP-OFF NHK SUNMED HOLDINGS LLC AF2142MB 201204 10889483090237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| D