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

Model Number	5704831
Medical Device Problem Codes	Failure to Deliver (2338); Complete Loss of Power (4015); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The logfile and information provided were analyzed for the investigation at the manufacturer site.Based on logfile of the affected device, the reported behavior was confirmed.In the course of investigation it was found that the ventilation was interrupted.The case was assessed to be reportable.The "charge internal battery" alarm and the "internal battery discharged" alarm were correctly displayed and warned the user about a low battery level.The ifu requires the internal battery to be removed and plugged in again as a remedy for this error message.Otherwise, the device might not switch back to external supply and stays in battery mode which can result in a fully depleted battery.As the use of the device was continued the ventilation finally stopped.There are known charging issues with oxylog 3000 plus and batteries with revision 25 and 26.One cause is a problem in the configuration of the battery pack, which can result in charging failures.As an aftereffect the device does not switch back to external supply and stays in battery mode which can result in a fully depleted battery.If the battery is further discharged the alarm "charge int.Battery" is displayed and in case of a discharged battery the device alarms visually and acoustically (alarm message "int.Battery discharged").The ventilation function stops.In this case an alternative independent ventilation device has to be used instantly, as described in the ifu.The further reported peep-valve inop failure message can be found in the error log file on the reported time.Charging parameters of new batteries have been adjusted.If the red charging status persists or occurs repeatedly at the end of the charging cycle, the battery must be replaced.The risk arising from the battery fault indication situation is covered by the risk management report, no previously undetected risks have arisen.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.
Event or Problem Description
It was reported that the internal battery failure whilst being used on a patient.Also failing device check (peep inop).The customer reported device failed while use on a patient.No patient health consequences have been 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: 21616231
• Report Number: 9611500-2025-00124
• Device Sequence Number: 15581074
• Product Code: CBK
• UDI-Device Identifier: 04048675249214
• UDI-Public: (01)04048675249214(11)170804(17)180728(93)5704833-26
• 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
• Type of Report: Initial
• Report Date (Section B): 03/17/2025

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: 5704831
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2017
• 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