BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRLIFE

    MDR report key: 19918978 · Received August 6, 2024

    Report

    Report Number
    8030673-2024-01016
    Event Type
    Injury
    Date Received
    August 6, 2024
    Report Date
    September 25, 2024
    Manufacturer
    VYARIE MEDICAL
    Product Code
    OFP
    UDI-DI
    10190752114364
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 06 AUG 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT 0004265545 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. WITHOUT A SAMPLE TO PERFORM FUNCTIONAL EVALUATION THE ROOT CAUSE CANNOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 25 SEP 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030673-2024-01011 FOR THE FIRST REPORT FDA USER FACILITY MW REPORT MW MW5156100 REPORTED, "DURING ENDOSCOPY, PATIENT BECAME HYPOXIC AND [THE] AMBUBAG WAS USED TO BAG VALVE MASK PATIENT, BUT DESPITE GOOD CHEST RISE AND POSITIVE END TIDAL CARBON DIOXIDE, PATIENT REMAINED HYPOXIC. WHEN [THE] PROVIDER REALIZED [THE] RESERVOIR BAG WAS NOT FULLY INFLATING, DIFFERENT BRAND AMBUBAG USED AND PATIENT'S HYPOXIA IMMEDIATELY RESOLVED...DURING THE DEFECTIVE DEVICE USE, [THE] PATIENT'S SATURATIONS DROPPED AS LOW AS 40%.".

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030673-2024-01011 FOR THE FIRST REPORT. FDA USER FACILITY MW REPORT MW MW5156100 REPORTED, "DURING ENDOSCOPY, PATIENT BECAME HYPOXIC AND [THE] AMBUBAG WAS USED TO BAG VALVE MASK PATIENT, BUT DESPITE GOOD CHEST RISE AND POSITIVE END TIDAL CARBON DIOXIDE, PATIENT REMAINED HYPOXIC. WHEN [THE] PROVIDER REALIZED [THE] RESERVOIR BAG WAS NOT FULLY INFLATING, DIFFERENT BRAND AMBUBAG USED AND PATIENT'S HYPOXIA IMMEDIATELY RESOLVED...DURING THE DEFECTIVE DEVICE USE, [THE] PATIENT'S SATURATIONS DROPPED AS LOW AS 40%." THE PATIENT'S CURRENT CONDITION WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703419 AIRLIFE AIRLIFE ADULT MANUAL RESUSCITATOR OXYGEN RESERVOIR BAG, PEEP VALVE, WITHOUT MASK OFP VYARIE MEDICAL 2K8033 0004265545 10190752114364

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R