BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANDA IRS

    MDR report key: 17548982 · Received August 15, 2023

    Report

    Report Number
    2112667-2023-03977
    Event Type
    Injury
    Date Received
    August 15, 2023
    Date of Event
    June 14, 2023
    Report Date
    September 20, 2023
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BTL
    PMA / PMN Number
    K070210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE HAS (GEHC) INVESTIGATION HAS BEEN COMPLETED. THERE IS NO ISSUE WITH THE IRES DEVICE. BOTH INFANTS WERE FOUND TO HAVE A PNEUMOTHORAX WHEN CHEST X-RAYS WERE PERFORMED IN THE NICU. IT IS NOT KNOWN WHETHER THE PNEUMOTHORAXES WERE SPONTANEOUS OR RELATED TO THE VENTILATION SUPPORT POSITIVE END-EXPIRATORY PRESSURE (PEEP) AT PEEP LEVELS CHOSEN BY THE CLINICIAN. THE IRES WAS FOUND TO BE WORKING TO SPECIFICATION WITH NO MALFUNCTIONS AND THE CLINICIANS DID NOT FEEL THAT THE DEVICE CAUSED THE PNEUMOTHORAX. THE PNEUMOTHORAX COULD HAVE BEEN SPONTANEOUS OR RELATED TO OTHER SECONDARY CAUSES OR BE IATROGENIC AND RELATED TO THE PEEP DELIVERED. AS THE CHOICE OF PEEP LEVEL IS MADE BY THE CLINICIAN, IF THE PNEUMOTHORAX WAS RELATED TO IT, SINCE THE IRES WAS WORKING TO SPECIFICATION, THE PNEUMOTHORAX COULD HAVE BEEN A COMPLICATION OF A THERAPY CHOSEN BY THE CLINICIAN AND THUS NOT CAUSED BY A GEHC DEVICE MALFUNCTION OR USE ERROR. H3 OTHER TEXT : GE HEALTHCARE HAS (GEHC) INVESTIGATION HAS BEEN COMPLETED. THERE IS NO ISSUE WITH THE IRES DEVICE. BOTH INFANTS WERE FOUND TO HAVE A PNEUMOTHORAX WHEN CHEST X-RAYS WERE PERFORMED IN THE NICU. IT IS NOT KNOWN WHETHER THE PNEUMOTHORAXES WERE SPONTANEOUS OR RELATED TO THE VENTILATION SUPPORT POSITIVE END-EXPIRATORY PRESSURE (PEEP) AT PEEP LEVELS CHOSEN BY THE CLINICIAN. THE IRES WAS FOUND TO BE WORKING TO SPECIFICATION WITH NO MALFUNCTIONS AND THE CLINICIANS DID NOT FEEL THAT THE DEVICE CAUSED THE PNEUMOTHORAX. THE PNEUMOTHORAX COULD HAVE BEEN SPONTANEOUS OR RELATED TO OTHER SECONDARY CAUSES OR BE IATROGENIC AND RELATED TO THE PEEP DELIVERED. AS THE CHOICE OF PEEP LEVEL IS MADE BY THE CLINICIAN, IF THE PNEUMOTHORAX WAS RELATED TO IT, SINCE THE IRES WAS WORKING TO SPECIFICATION, THE PNEUMOTHORAX COULD HAVE BEEN A COMPLICATION OF A THERAPY CHOSEN BY THE CLINICIAN AND THUS NOT CAUSED BY A GEHC DEVICE MALFUNCTION OR USE ERROR.

    Additional Manufacturer Narrative · 0

    GEHC FIELD ENGINEER (FE) CHECKED THE DEVICE AND FOUND THE DEVICE WAS FUNCTIONING PROPERLY, WITH NO DEFECTS OBSERVED. GEHC'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A5 AND A6: NO INFORMATION AVAILABLE. BLOCK D4 UNIQUE IDENTIFIER: (B)(4). LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED TO GE HEALTHCARE (GEHC) THAT A PATIENT EXPERIENCED PNEUMOTHORAX DURING USAGE OF A PANDA IRES WARMER AND THAT THE HOSPITAL DID NOT BELIEVE THAT USAGE OF THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S PNEUMOTHORAX. POSITIVE END-EXPIRATORY PRESSURE (PEEP) VIA GEHC IRES T-PIECE CIRCUIT WITH MASK WAS PERFORMED BY THE MEDICAL STAFF, AND A CHEST X-RAY DONE LATER SHOWED A RIGHT SIDE PNEUMOTHORAX, WHICH REQUIRED THE PATIENT TO BE INTUBATED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL THAT COULD PROVIDE HIGHER LEVEL NICU CARE. THE CHEST TUBE WAS REMOVED FROM THE PATIENT ON (B)(6) 2023, AND THEY WERE DISCHARGED, WITH NO COMPLICATION, ON (B)(6) 2023. GEHC WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963542 PANDA IRS VENTILATOR,EMERGENCY,(RESUSCITATOR) BTL DATEX-OHMEDA, INC. M1112198

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Male