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

Model Number	5704831
Medical Device Problem Codes	Failure to Run on Battery (1466); Failure to Deliver (2338); Complete Loss of Power (4015)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
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 an oxylog was turning off spontaneously mid patient transfer, we've requested further information but have only been able to get the below information details are ¿low physical harm¿ experienced by the patient, with reports of loss of etco2 and not ventilating.It was reported that the patient¿s condition temporarily decreased / low physical harm was reported.No serious injury.
Additional Manufacturer Narrative
For investigation at the manufacturer site the logfile and description of event and provided photo were analyzed.According to the investigation results it could be confirmed that the device stopped ventilation due to a discharged battery.The battery index was revision index 20, with the label "use until 2021-03".After the logbook analysis, the device behaved as specified and alerted correctly.The ¿charge internal battery¿ alarm was alarmed for 10 minutes until the device alarmed ¿internal battery discharged¿ and turned off.This corresponds to the specification and the normative reserve.During the onsite examination by a service technician, the fully charged battery ran for over 7 hours.Based on the test results, a malfunction of the device can be excluded.It was reported that the patient's condition temporarily deteriorated / minor physical impairment was reported.No serious injury, medical interventions or prolonged health consequences were reported.In case of a charging error the battery led shows 'red', alarm message "no int.Battery charging" is displayed if device is powered on.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 may stops after that alarm.In this case an alternative independent ventilation device has to be used instantly, as described in the ifu.
Event or Problem Description
It was reported that an oxylog was turning off spontaneously mid patient transfer, we've requested further information but have only been able to get the below information details are ¿low physical harm¿ experienced by the patient, with reports of loss of etco2 and not ventilating.It was reported that the patient¿s condition temporarily decreased / low physical harm was reported.No serious injury.

• 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: 20319735
• Report Number: 9611500-2024-00421
• Device Sequence Number: 15499680
• Product Code: CBK
• UDI-Device Identifier: 04048675249214
• UDI-Public: (01)04048675249214(11)200707(93)5704833-36
• 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,Followup
• Report Date (Section B): 11/28/2024

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: 5704831
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 11/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2020
• 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