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

Model Number	5704811
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Deliver (2338)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	04/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the placement of a central venous catheter, it was noted that the patient was not being ventilated through the device.There was no chest movement of the patient.There was no alarm from the device.The patient then became bradycardic and required resuscitation and had to be ventilated manually.After successful resuscitation, the device was put back into operation and showed no abnormalities.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
The affected device was tested by dräger service, and the logbook was available for analysis.A complete functional test showed no device malfunction.The logbook shows that the device successfully passed the self-test on the morning of the incident.Ventilation was started at 11:15 a.M., and the next user interaction took place at 12:07 p.M.During the subsequent ventilation, various alarms occurred regarding high airway pressure, low airway pressure, high minute volume, low minute volume, and insufficient o2 supply pressure.The next time user interaction with the device was at 1:25 p.M., and an alarm reset was recorded at 1:31 p.M.Based on the logbook entries, no user responses to the alarms can be seen up to this point.There is no indication of a technical error in the logbook.In the event of a technical problem, the device would alert the user acoustically and visually, thus informing them of an existing malfunction.If the ventilator completely loses function, ventilation is stopped and the safety valve opens, allowing the patient to breathe spontaneously.To continue ventilation in such a case, an alternative device must be used.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 during the placement of a central venous catheter, it was noted that the patient was not being ventilated through the device.There was no chest movement of the patient.There was no alarm from the device.The patient then became bradycardic and required resuscitation and had to be ventilated manually.After successful resuscitation, the device was put back into operation and showed no abnormalities.

• 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: 21958704
• Report Number: 9611500-2025-00223
• Device Sequence Number: 7272780
• Product Code: CBK
• UDI-Device Identifier: 04048675249221
• UDI-Public: (01)04048675249221(11)141031(93)5704811-19
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 5704811
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown