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

Model Number	5704110
Medical Device Problem Codes	Gas Output Problem (1266); Decreased Pump Speed (1500); Failure to Deliver (2338)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the carina ventilator triggered a technical alarm.The alarm occurred while the device was connected to the patient.According to the user, a backup ventilator was immediately available.The patient¿s oxygen saturation subsequently stabilized again.No further complications or medical interventions involving the patient were reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.

• Brand Name: CARINA
• Common Device Name: VENTILATORS, OTHERS
• 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: 25358724
• Report Number: 9611500-2026-002565
• Device Sequence Number: 15925870
• Product Code: CBK
• UDI-Device Identifier: 04048675041610
• UDI-Public: (01)04048675041610(11)151102(93)8419350-27
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2026

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): Follow-Up
• Initial Date Received by Manufacturer: 05/21/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2015
• 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