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

Model Number	8606500
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the device stopped ventilating during a case.They rebooted the unit and it started working again.The case was finished.No reported patient injury.The device has no udi as an udi was not required at the time the device was manufactured.
Additional Manufacturer Narrative
For the investigation the logfile was analysed.The described problem could be retraced.It was found that during the relevant procedure, the ventilator detected a wrong motor position and forced an autonomous shutdown to safety mode.In this state the ventilator changes to man/spont (safety mode) and generates the appropriate ventilator fail alarm.Manual ventilation remains possible as it was in this special case.The therapy was continued using manual ventilation.The user restarted the device (power off/on) and continued therapy without any further problems.The analysis of the device logfile revealed no indications for a general motor- or motor control problem.It is therefore possible that the patient's coughing reported led to a blockage of the ventilator, but transient contamination of the encoder disk/light barrier also appears to be a conceivable cause.On site the device was tested according to manufacturer's specification and returned into use.The exact root cause couldn¿t be determined.It can be concluded that the device reacted as specified with an autonomous shutdown of the ventilator and alarmed audible and visible for ventilator fail while autonomously changing to manual ventilation (man/spont).Manual ventilation remained unaffected, as specified.All alarms, possible causes and remedies are described in the instructions for use.
Event or Problem Description
It was reported that the device stopped ventilating during a case.They rebooted the unit and it started working again.The case was finished.No reported patient injury.The device has no udi as an udi was not required at the time the device was manufactured.

• 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: 22402919
• Report Number: 9611500-2025-00351
• Device Sequence Number: 15542051
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)210421(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): 08/15/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• 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