MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA CARINA; VENTILATORS, OTHER

Model Number	8419350
Medical Device Problem Codes	Gas Output Problem (1266); Inaccurate Delivery (2339)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/12/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that the device alarmed and switched to backup ventilation during use.The ventilation was performed with settings for apnea.It was reported that vitals were deteriorating.It was further reported that the patient passed away two hours after the event, but the connection to the event has not been specified.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.
Event or Problem Description
It was reported that the device alarmed and switched to backup ventilation during use.The ventilation was performed with settings for apnea.It was reported that vitals were deteriorating.It was further reported that the patient passed away two hours after the event, but the connection to the event has not been specified.
Additional Manufacturer Narrative
The log file of the affected device was provided for the investigation.The log entries show that the device has been performing a ventilation starting on (b)(6) 2023 at 06:21 and continued with short user-initiated standby phases.On (b)(6) at 02:14 the device logged the technical error 00.A018 / emergency backup ventilation.In reaction to the error the user set the device to standby and restarted the ventilation again.The alarm message was given again 21 times until the device was switched off by the user at 02:40.The error message indicates that the pressure sensor is faulty.Based on the log entries the root cause of the error is a faulty pressure sensor ps1 which showed an offset voltage that was outside of the specified range.The device can be repaired by replacing the pressure measurement unit of the pcb sensor.The carina is a long-term ventilator intended for sub-acute care patients.Sub-acute care refers to patients who are stable and require diagnostic and invasive procedures but not intensive treatment.In case of the sensor related technical error 00.A018 "pressure sensor failure" the device switches to emergency ventilation with 21 vol% fio2.The turbine maintains controlled ventilation with the required ventilation pressure even if the sensors fail.Emergency ventilation is pressure-controlled ventilation with reduced quality and is alarmed with "emergency ventilation !!!".In case of this alarm the ifu advises the user to start using an independent substitute device to continue the ventilation of the patient.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: CARINA
• Common Device Name: VENTILATORS, OTHER
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 18397121
• Report Number: 9611500-2023-00523
• Device Sequence Number: 11456393
• Product Code: CBK
• UDI-Device Identifier: 04048675041610
• UDI-Public: (01)04048675041610(11)160818(17)161110(93)8419350-28
• Combination Product (Y/N): N
• PMA/510(K) Number: K072885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 8419350
• Device Catalogue Number: 5704110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown