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

Model Number	5704110
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Deliver (2338); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the device switched off during operation with a continuous tone and a a white screen incl.Alarm message.The device immediately activated a continuous high-pitched alarm.The user was able to react in time and provide a replacement device.No health consequences were reported.
Additional Manufacturer Narrative
For the investigation, the information provided including the logbook of the affected carina device with serial no.(b)(6) manufactured in june 2017, was analyzed.The reported event, the stop of the ventilation could thus be traced.The device ran for over 60 minutes in battery mode and triggered an alarm.However, the high-priority alarm described in the ifu (>3min) before the device was switched off was not observed.The frequently used internal battery was at the end of its life cycle and the power supply for the correctly timed alarm was not fully available.The device went into standby with a high-priority alarm.The device then switched itself off and then issued the other high-priority buzzer alarm as specified.There were no health consequences for the patient.If the device switches off during operation and has not been switched off via the main switch, the power failure alarm sounds as a long-lasting buzzer signal.The battery alarms are explained in the operating instructions with details of the recommended measures, where reference is also made to restoring the mains supply as soon as possible.In the event of a complete loss of function, an emergency ventilation valve would open and allow the patient to breathe spontaneously.Ventilation of the patient with an independent ventilator may be considered necessary.Switching on or starting the device in this deeply discharged state is only possible after the mains supply has been restored.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported that the device switched off during operation with a continuous tone and a a white screen incl.Alarm message.The device immediately activated a continuous high-pitched alarm.The user was able to react in time and provide a replacement device.No health consequences were reported.

• 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 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 24035514
• Report Number: 9611500-2026-00008
• Device Sequence Number: 9260492
• Product Code: CBK
• UDI-Device Identifier: 04048675398516
• UDI-Public: (01)04048675398516(11)170619(17)171028(93)5704110-12
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5704110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2017
• 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
• Patient Sex: Unknown