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

Model Number	8606500
Medical Device Problem Codes	Failure to Deliver (2338); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
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 a ventilator failure occurred during use of the device.Mechanical ventilation was no longer possible.It was switched to manual ventilation.After restart of the anesthesia device the surgery was continued.
Additional Manufacturer Narrative
The device was subject to an on-site evaluation performed by a dräger service engineer.It was not possible to reproduce the reported failure.The ventilator unit has been replaced.Thereby, it was found that the diaphragm had wrinkles.This could also be comprehended by means of the fotos provided.Traces of bending lines indicate that the diaphragm possibly got wrinkled during operation.According to the logfile records the ventilator detected a wrong motor position during the reported time in question.As a consequence the ventilator initiated an autonomous shutdown while changing mode to man/spont and generating the appropriate ventilator fail alarm.Manual ventilation remains possible in this case.Based on the available information the root cause could not be clearly determined.But it it possible that the motor was briefly blocked due to external influences as an external gas measurement (applying a sample gas flow) was used.The device has reacted as specified for the detected situation by switching off the ventilator and generating appropriate alarms.Finally, the device was tested and returned to use without further problems reported.The field failure rate is subject to permanent monitoring by the responsible product quality board and is rated as acceptable.
Event or Problem Description
It was reported that a ventilator failure occurred during use of the device.Mechanical ventilation was no longer possible.It was switched to manual ventilation.After restart of the anesthesia device the surgery was continued.

• 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: 21176434
• Report Number: 9611500-2025-00034
• Device Sequence Number: 17215125
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)190528(93)8606500-66
• 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): 02/20/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown