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	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.
Event or Problem Description
It was reported that the unit failed at the end of case with a ventilator failure.No patient harm reported.
Event or Problem Description
It was reported that the unit failed at the end of case with a ventilator failure.No patient harm reported.
Additional Manufacturer Narrative
The investigation was based on log file analysis and revealed that the sw could sporadically not detect the signal of the pressure sensor which monitors the pressure inside the cylinder of the ventilator.To protect the patient from potentially hazardous output, the device is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.Manual ventilation with the built-in breathing bag is still possible; the monitoring functions remain unaffected.The root cause for the signal loss could not be determined - the device was subject to an on-site test and did not exhibit any deviations.A plausible explanation would be that humidity has disturbed the signal detection of the sensor temporarily - traces for that cannot be found afterwards due to evaporation.Dräger finally concludes that the device responded as designed upon the underlying error condition.The number of similar cases related to the same root cause is within accepted range.

• 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: 21489717
• Report Number: 9611500-2025-00094
• Device Sequence Number: 12898314
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)220914(93)8606500-70
• Combination Product (Y/N): N
• 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): 03/26/2025

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: 01/30/2025
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• 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