MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA OXYLOG 3000PLUS; VENTILATORS, TRANSPORT

Model Number	5704811
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an external examination on a patient the device alarmed indicating "!!! device malfunction", and it stopped working immediately upon alarm.No injury or health consequences for the patient were reported.
Additional Manufacturer Narrative
It was reported that during use on a patient the device generated the alarm "device malfunction" and stopped ventilation.No injury or health consequences for the patient were reported.Reportedly a product issue was identified, and the user repaired the device ¿ dräger was not contacted regarding the repair and no information regarding the repair activities is available.Dräger attempted to obtain further information, but this was not successful; a case-specific evaluation is thus not possible and no root cause can be determined.No involvement or service contract with draeger - the manufacturer is not able to draw a concrete conclusion about the root cause of the reported " device malfunction" but it can be emphasized that the situation was alarmed and displayed by the device.The user of this emergency ventilator is always present and can change to an alternative ventilation method that according to the ifu has always to be kept as a back-up immediately.

• Brand Name: OXYLOG 3000PLUS
• Common Device Name: VENTILATORS, TRANSPORT
• 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: 22034210
• Report Number: 9611500-2025-00255
• Device Sequence Number: 12925607
• Product Code: CBK
• UDI-Device Identifier: 04048675249221
• UDI-Public: (01)04048675249221(11)201105(93)5704811-22
• Combination Product (Y/N): N
• PMA/510(K) Number: K103625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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: 5704811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown