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

Model Number	8606500
Medical Device Problem Codes	Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the unit failed on a patient with ventilator failure.They had to bag patient to finish.No reported patient injury.
Additional Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.
Additional Manufacturer Narrative
The electronic device log file was available for investigation.The reported ventilator failure could be reconstructed by means of the information stored in the log file.During the case in question, the apollo detected a deviation between the measured and the expected position of the ventilator piston.The device reacted in accordance with its implemented safety concept as it interrupted automatic ventilation, switched to man/spont mode and generated a corresponding audible and visible ventilator fail alarm.In such case both manual ventilation and monitoring functions will remain unaffected and available.Hence, the user is able to ventilate the patient manually and monitor relevant information regarding ventilation and gas delivery as it ws done in this case.It was concluded that a faulty motor has caused the reported stop of ventilation.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 field failure rate is subject to permanent monitoring by the responsible product quality board and is rated as acceptable.
Event or Problem Description
It was reported that the unit failed on a patient with ventilator failure.They had to bag patient to finish.No reported patient injury.

• Brand Name: APOLLO
• Common Device Name: ANESTHESIA UNITS
• 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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 21650255
• Report Number: 9611500-2025-00137
• Device Sequence Number: 9401885
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)241010(93)8606500-72
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 04/23/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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