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

Model Number	5704110
Medical Device Problem Codes	Gas Output Problem (1266); Unexpected Therapeutic Results (1631); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 inhalation therapist saw on the "technical problem" screen that the display was no longer responding and the on/off button was not working.The inhalation therapist had to unplug the device to turn it off.No patient health consequences have been reported.
Additional Manufacturer Narrative
The investigation was based of the analysis of given information and log inspection of the affected carina.The logfile showed that the power switch was switched off during active ventilation at the reported time.The device alarmed as specified.The switch off procedure is described in the ifu.It is not possible to do this directly.The user must stop the ventilation, this sets the device in the standby state.Then, the power switch can be switched off and the device will shut down.This is the intended safety behavior.If the power switch is switched off during active ventilation, a corresponding alarm message is displayed.No technical could be detected failure, also nor hints of a non-working display can be found.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.Based on the investigation results this case is considered not to be reportable according to the medical device regulation (mdr 2017/745) as neither death nor a serious injury were caused, nor would it be expected to occur in case of recurrence.
Event or Problem Description
It was reported that the inhalation therapist saw on the "technical problem" screen that the display was no longer responding and the on/off button was not working.The inhalation therapist had to unplug the device to turn it off.No patient health consequences have been 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: 24425581
• Report Number: 9611500-2026-00076
• Device Sequence Number: 9730744
• Product Code: CBK
• UDI-Device Identifier: 04048675398516
• UDI-Public: (01)04048675398516
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/07/2026

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2015
• 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