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

Model Number	8606500
Medical Device Problem Codes	Degraded (1153); Gas Output Problem (1266); Failure to Deliver (2338); No Pressure (2994)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was just starting.The result will be forwarded in a follow up report.
Event or Problem Description
It was reported that on (b)(6) 2025 a ventilator malfunction occurred during surgery and mechanical ventilation was stopped.Manual ventilation was substituted and surgery continued.No injury was reported.
Event or Problem Description
It was reported that on (b)(6) 2025 a ventilator malfunction occurred during surgery and mechanical ventilation was stopped.Manual ventilation was substituted and surgery continued.No injury was reported.
Additional Manufacturer Narrative
For the investigation the provided logfile was analysed.The described ventilator failure could be reproduced.It was found that traced back to an error condition with the ventilator motor.The motor unit was replaced; the device passed all consecutive tests and could be returned to use.The motor was returned to the manufacturer and inspected in detail.A not stable electrical contact between the motor collector and the carbon brushes during motor operation was found.The root cause was most probably a deteriorated spring at the carbon brushes which led to a reduced force by which the carbon brushes are pressed against the collector, intermittent contact losses are the consequence.This leads to speed fluctuations and may cause that the motor does not reach the intended position.The motor that drives the piston ventilator is a so-called step motor - the number of rotations define the piston hub which is a measure for the tidal volume the ventilator applies.If the aforementioned speed fluctuations exceed a certain threshold and the supervisor function of the software detects two consecutive instances of significant deviation between calculated/intended and measured motor position, the device shuts down automatic ventilation to protect the patient from potentially hazardous output.This is accompanied by a corresponding alarm.As it was done in this case, the user may continue patient support in manual ventilation mode with the built-in breathing bag; gas dosage and monitoring functionalities remain unaffected from the ventilator shutdown.Dräger finally concludes that the system responded as designed upon a deviation in one subsystem.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: 21695996
• Report Number: 9611500-2025-00152
• Device Sequence Number: 9308608
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)200128(93)8606500-67
• 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): 05/13/2025

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: 03/12/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2020
• 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