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

Model Number	5704811
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Sense (1559); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
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 a ¿technical failure¿ alarm occurred whilst in use on patient.Reportedly, the device was swapped out.There were no health consequences for the patient reported.
Additional Manufacturer Narrative
The investigation was based on the reported event and log analysis of the affected oxylog 3000plus with product serial no.(b)(6), manufactured in june 2016.According to the logfile a technical failure could be confirmed at the reported time.The failure "sensor: s6 out of range" was logged, indicating that the measurement value of sensor s6 was outside the physical range.The device alarmed as specified and the ventilation function stops.In case of a technical problem (e.G."'technical failure' alarm has occurred") the device alarms visually and acoustically.The user replaced the device immediately.The patient didn't sustain any health consequences.This failure is usually caused by either the autozero valves or the sensor pcb.Since the same device failed 2 days earlier with the identical technical defect during use, we strongly recommend to check and repair the device according to the manufacturer's specifications before the next use.These parts usually do not need to be replaced during lifetime of the device, however in isolated cases they may need to be replaced.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 a ¿technical failure¿ alarm occurred whilst in use on patient.Reportedly, the device was swapped out.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: 19687523
• Report Number: 9611500-2024-00280
• Device Sequence Number: 8131001
• Product Code: CBK
• UDI-Device Identifier: 04048675249221
• UDI-Public: (01)04048675249221(11)160610(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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 06/26/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2016
• 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