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

Model Number	5704833
Medical Device Problem Codes	Failure to Charge (1085); Failure to Run on Battery (1466); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that as the battery capacity started to decrease during use on a patient the user started charging the battery.Then the device alarmed int.Battery charging inop.The user detached and attached the battery which resulted in a device switching off while the battery was detached.No patient injury was reported.
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 as the battery capacity started to decrease during use on a patient the user started charging the battery.Then the device alarmed int.Battery charging inop.The user detached and attached the battery which resulted in a device switching off while the battery was detached.No patient injury was reported.
Additional Manufacturer Narrative
The affected device was checked by dräger service and the log file was provided for further investigation.During the device check five charging cycles were performed during which the charging failure could not be reproduced.Based on the log file it could be confirmed that the device alarmed ¿no int.Battery charging¿ on june 19th at 14:25, 14:38 and 14:39.At 14:53 the user detached the battery resulting in a restart of the device and at 15:09 the user switched the device off.It can be assumed that temporary issue was resolved by removing and reinserting of the battery.However, as a precaution the battery and charger pcb of the affected device were replaced.The current state of charge can be read after power on in the configuration menu in percent and during ventilation as a symbol in 25% steps.The alarm "! no int.Battery charging" indicates that the battery cannot be charged due to a faulty battery or too hot or cold environment.In case of this alarm the device continues operation until the battery is discharged.Alternatively, the user can reconnect the device to mains power in order to continue operation.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• 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: 22584938
• Report Number: 9611500-2025-00406
• Device Sequence Number: 4565050
• Product Code: CBK
• UDI-Device Identifier: 04048675249214
• UDI-Public: (01)04048675249214(11)201203(93)5704833-36
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/27/2025

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: 5704833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2020
• 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.; NA.
• Patient Sex: Unknown