MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA APOLLO; ANESTHESIA UNITS

Model Number	8606500
Medical Device Problem Codes	Degraded (1153); Failure to Deliver (2338); No Pressure (2994)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A dräger service engineer has checked the device on-site; the reported ventilator failure during use can be confirmed.The engineer was able to trace it back to the ventilator motor; the supervisor function of the software has detected an encoder check error caused by fluctuations of the rotating speed and responded to that by forcing a safety shut down of automatic ventilation and by alerting the user to this condition by means of a corresponding alarm.The mechanism of fault can be explained as follows: the device facilitates a piston ventilator.The applied tidal volume is controlled via the piston hub.The number of rotations of the step motor defines the piston hub; speed deviations of the motor caused by wear and tear may result in a divergence between expected and measured piston position.To protect the patient form potentially hazardous output, the device is designed to shut-down automatic ventilation.Manual ventilation via the built-in breathing bag as well as the monitoring functions remain unaffected.Dräger finally concludes that the device responded as intended upon the underlying error condition.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.The motor exchange has put back the device into fully operable conditions.
Event or Problem Description
It was reported that automatic ventilation failed during use of the device.It was later confirmed to dräger that the event did not lead to consequences for the patient.

• Brand Name: APOLLO
• Common Device Name: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA

4518822868

• MDR Report Key: 22976059
• Report Number: 9611500-2025-00504
• Device Sequence Number: 8972626
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)200722(17)250306(93)8606500-67
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

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: 8606500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2020
• 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