MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SAVINA 300; VENTILATOR, INTENSIVE CARE

Model Number	8417801
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported in an ufr to dräger that the screen of the ventilator suddenly turned black during use and that ventilation stopped.As per report, the users bridged patient support with a manual breathing bag until a replacement device could be introduced; it was stated that the event did not lead to health consequences for the patient.
Additional Manufacturer Narrative
The ufr was the only information for this case; the hospital did not involve the local dräger s&s organization into any follow-up measures.The contact person named in the ufr could not provide further information.Dräger is unable to perform a case-specific evaluation, the following can be derived from the available details: the description of event would suggest that the device shut itself down due to complete loss of energy.If this postulation is correct, it can be stated that the device posted a corresponding alarm via a buzzer for at least two minutes, this buzzer is powered by an independent power source (goldcap capacitor).The particular model is equipped with an internal battery that is capable to supply the device with energy in case of mains power losses for at least 30 minutes.Hence, it is nearly to be excluded that the reported shut-down occurred in single-fault conditions.It would be plausible that the device was put into operation with a completely worn internal battery which could not supply the device with energy when mains power got lost for whaever reason.Other scenarios may apply as well.Dräger cannot draw a reliable conclusion without the possibility to inspect the device.Multiple aspects must be taken into consideration as contributing factors - these include component malfunctions, infrastructure problems, lack of preventive maintenance and use errors.

• Brand Name: SAVINA 300
• Common Device Name: VENTILATOR, INTENSIVE CARE
• 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 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 25326870
• Report Number: 9611500-2026-00258
• Device Sequence Number: 9838363
• Product Code: CBK
• UDI-Device Identifier: 04048675411628
• UDI-Public: (01)04048675411628(11)180822(93)8417801-37
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K003068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: 8417801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2018
• 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