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

Model Number	8606500
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Analyze Signal (1539); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.We will provide results with a separate follow-up report.
Event or Problem Description
Reportedly mechanical ventilation ceased during use.The device posted a corresponding alarm.There was no injury reported.
Event or Problem Description
Reportedly mechanical ventilation ceased during use.The device posted a corresponding alarm.There was no injury reported.
Additional Manufacturer Narrative
Based on the analysis of the device logfile, the case could be reconstructed.It was found that the device detected a wrong motor position.In such case, to protect from potentially hazardous output and/or from serious damages to the ventilator unit, the device is designed to shut down automatic ventilation and to post a corresponding alarm.Manual ventilation is further available as well as the monitoring functions of the device are.It was further reconstructed that the user continued therapy by using manual ventilation until the device was restarted by the user.After successful completion of the power- on self-test (post), therapy was continued using pressure support mode without any further issues.The log analysis revealed no indications for a general motor- or motor control problem.Since there were no problems observed during piston referenciation during post either, a motor failure seems unlikely.Thus, most likely foreign objects in the light barrier or a contaminated encoder disc was disturbing the correct detection of the motor position and in consequence to the reported symptom.Dräger finally concludes that the device behaved as specified upon the detected issue; no patient consequences have been reported.The device was inspected in follow-up to the event and no indications for a technical device failure were found either.After testing, the device was returned back to use, and no further problems have been reported.The number of similar cases, related to the same phenomenon, is within the expected range of the respective risk assessment and thus accepted.

• 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: 20964261
• Report Number: 9611500-2024-00582
• Device Sequence Number: 12823043
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)191210(93)8606500-67
• 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): 02/03/2025

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: 12/02/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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