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

Model Number	8606500
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hospital's biomed was seeking dräger's assistance, provided a log file and reported that a cut in the lower ventilator piston diaphragm was found during inspection of the device.Upon log file review, dräger confirms that the cut in the diaphragm had caused the shut down of automatic ventilation.The failure mechanism can be explained as follows: the device is equipped with a pump that generates an auxiliary vacuum pressure which is needed to actuate the valves that control the ventilation cycles and to keep the piston diaphragm in place during ventilator operation.To protect the patient from potentially hazardous output of pressure and flow and to prevent from serious damages to the ventilator unit the device is designed to shut down automatic ventilation when the vacuum pressure drops below a certain threshold.The shut-down is accompanied by a corresponding alarm, manual ventilation via the built-in breathing bag will still be possible, and the monitoring functionalities remain unaffected as well.The biomed confirmed that replacement of the diaphragm has put back the device into fully operable state.The ffr of the diaphragm is inconspicuous and accepted.
Event or Problem Description
It was reported that the device shut down automatic ventilation during use while posting a corresponding alarm.The event did not lead to consequences for the patient.

• Brand Name: APOLLO
• Common Device Name: ANESTHESIA MACHINE
• 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: 22673701
• Report Number: 9611500-2025-00425
• Device Sequence Number: 18013905
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)181220(93)8606500-65
• 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): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2018
• 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