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

Model Number	5704811
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Deliver (2338); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2025
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 failed whilst ventilating a patient.There were no health consequences for the patient reported.
Additional Manufacturer Narrative
The log file of the affected device was analysed regarding the reported event.The log file analysis could confirm that the device shut down due to an overaged battery.The log file analysis showed that the device alarmed ¿charge int.Battery¿ to inform the user.However, as the battery was out of date, the battery was unable to hold the charge as specified, causing the supply voltage to collapse prematurely.The overaged battery was already replaced by the dräger service.The device was tested and confirmed to be operating as per manufacturer¿s specification.In case of using an out of date battery the risk of malfunctions of the battery rises.In case of a low state of charge the device alarms visually and acoustically.Potentially the ventilation may stop when the battery is fully depleted.As mentioned in the instructions for use it is recommended to have a fully charged spare battery available when using the device.Ventilation will always resume with the last values settings approximately 3 seconds after inserting a recharged battery.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported that the device failed whilst ventilating a patient.There were no health consequences for the patient reported.

• 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: 22564362
• Report Number: 9611500-2025-00398
• Device Sequence Number: 19838907
• Product Code: CBK
• UDI-Device Identifier: 04048675249221
• UDI-Public: (01)04048675249221(11)230215(93)5704811-24
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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