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

Model Number	5704110
Medical Device Problem Codes	Gas Output Problem (1266); Decreased Pump Speed (1500); Failure to Deliver (2338)
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 during use, the carina stopped working mid-ventilation on a patient.The battery was charged and unplugged; it started up fine on battery power and held the charge.Customer is afraid it might be a major problem.
Additional Manufacturer Narrative
The affected carina device was analyzed via provided information incl.Log analysis and onsite inspection.According to the investigation results a stop of ventilation could be confirmed via the logfile at the reported time.The device alarmed and behaved as specified.The internal inspection onsite found out that the blower was out of place inside the blower unit.It was repaired and successfully tested according to manufacturer specs afterwards.The ventilator carina continuously monitors the status and function of the internal components, sensors and software modules.If a deviation is or a failure of the ventilation is detected in the safety software, carina will give visual and audible alarms.This would be visible in the device log.In case of totally loss of functionality, power fail alarm is activated.An emergency breathing valve allows spontaneous breathing of the patient.Ventilation of the patient with an independent ventilation device may be considered necessary.The risk assessment concerning the reported event does not reveal any new or additional risk with respect to the known risks at the time of product design, during product improvement process and risks to be expected in the frame of the intended purpose, consequently, this is considered within the device safety concept.
Event or Problem Description
It was reported that during use, the carina stopped working mid-ventilation on a patient.The battery was charged and unplugged; it started up fine on battery power and held the charge.Customer is afraid it might be a major problem.

• Brand Name: CARINA
• Common Device Name: VENTILATORS, OTHER
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): BAY STATE ANESTHESIA; 30 willow street; north andover MA 01845
• Manufacturer Contact: 30 willow street; north andover, MA 01845 ; 4518822868
• MDR Report Key: 24425578
• Report Number: 9611500-2026-00077
• Device Sequence Number: 9730741
• 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