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); Complete Loss of Power (4015); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a case which had occurred on (b)(6) 2026 at 8:15am, the device suddenly had a ventilator failure and switched to manual mode.The hospital biomed has not been able to duplicate the reported issue.No reported patient injury.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.

• 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 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 24827246
• Report Number: 9611500-2026-00150
• Device Sequence Number: 18447155
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)220707(93)8606500-70
• 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): 05/18/2026

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: 03/17/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• 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