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); Insufficient Flow or Under Infusion (2182); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was just started, the result will be forwarded in a follow up report.
Event or Problem Description
It was reported that system failed during case.No injury reported.
Event or Problem Description
It was reported that system failed during case.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 forced a shutdown of automatic ventilation due to a detected wrong motor position.To prevent from damages, the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.Manual ventilation and the monitoring functions remain available to the full extent.During on-site checking in follow-up to the event, it was found that the o-ring had come loose, which fixes the rolling diaphragm to the piston.It could be concluded that most likely either the o-ring or mechanical abrasion of the diaphragm caused an incorrect reading of the encoder disk, or the piston got blocked due to increased mechanical stress caused by the detached rolling diaphragm.The exact root cause could not be finally determined.Neither can the loosening of the o-ring finally be determined.An assembly error and/or unusual mechanical contact between the lower piston housing and the piston very likely caused the o-ring to get detached from the diaphragm/piston.Since the replaced parts were not available for investigation, the exact root cause could not be finally determined.Nevertheless, dräger finally concludes that the device behaved as specified upon the detected wrong motor position; no patient consequences have been reported.On-site, the lower diaphragm and o-ring as well as upper diaphragm have been replaced accordingly.After the replacement, the device passed testing and was returned back to use with no further problems reported.The number of similar cases, related to the same root cause, 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: 22661599
• Report Number: 9611500-2025-00419
• Device Sequence Number: 3678145
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)210329(93)8606500-68
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042607
• 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): 09/08/2025

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: 07/09/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2021
• 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