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

Model Number	8414000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the intensive care ventilator suddenly posted an alarm during use, shut itself off and could not be restarted.As per report, the users have connected the patient to another device; no health consequences have occurred, finally.
Additional Manufacturer Narrative
The involved device is eight years old and not under a service contract; the user facility did not involve the local dräger s&s organization into examination and repair of the device.Dräger contacted the hospital for the purpose to obtain further information but no additional details could be provided.The ufr was the only source of information which does not allow a case-specific evaluation.The following can be derived: a shut-down would suggest that the device ran out of electrical energy.Since the workstation is equipped with an internal battery to cover mains power losses, the shut-down cannot have occurred in single-fault condition.The simplest explanation would be that the device was not connected to mains supply and operated on internal battery until the latter was depleted.It would also be imaginable that the device was put into operation with a completely worn internal battery and a malfunction in the power supply had occurred, or the latter has switched itself off due to overheating because the dust filter at the opening through which the device takes in ambient air for cooling was clogged.Other explanations may apply as well, a differentiation on the base of the very few transmitted information is not possible.Component malfunctions, use errors, infrastructure issues, lack of preventive maintenance or a combination of these factors have caused or contributed to the event.The device is designed to post an acoustical alarm at complete loss of power which is buffered by an independent power source - this alarm has reportedly been posted.

• Brand Name: SAVINA
• 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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 22174005
• Report Number: 9611500-2025-00295
• Device Sequence Number: 15832716
• Product Code: CBK
• UDI-Device Identifier: 04048675407881
• UDI-Public: (01)04048675407881(11)170227(93)8414000-36
• Combination Product (Y/N): N
• 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): 06/10/2025

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: 8414000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2017
• 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