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

Model Number	8414000
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The report was received via the chinese user facility reporting program - against the description of event in this ufr ("after adjusting the ventilator, normal ventilation was restored") the following "initial treatment: replacement of the ventilator, after active resuscitation of the patient and the patient recovery" was noticed.The hospital did not report to dräger directly and did also not involve the local dräger s&s organization into any follow-up measures.No further information could be obtained, a case specific evaluation is not possible and the contradiction if the ventilator was exchanged or re-adjusted could not be clarified.No further details about device settings, alarms or behavior during the event are known - the affected device was manufactured in september 2019 - its state of maintenance and repairs is unknown to the manufacturer.The aspect that normal function of the ventilator was restored after adjusting the settings would suggest that indeed there was no technical issue with the machine.If, for example, the device was used in non-invasive ventilation mode with apnea ventilation set to off, the device would not apply mandatory breaths when the patient's own breathing stopped due to the health condition.
Event or Problem Description
It was reported that during an ongoing ventilation the patient appeared pale with low oxygen saturation - immediate assessment revealed the ventilator had stopped functioning - reportedly after adjusting the ventilator, normal ventilation was restored.It was further reported that, after the following active resuscitation, the patient's heart rate recovered, and complexion returned to normal - patient's condition was continously monitored then.

• Brand Name: SAVINA
• Common Device Name: VENTILATORS, 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: 24649535
• Report Number: 9611500-2026-00115
• Device Sequence Number: 21272389
• Product Code: CBK
• UDI-Device Identifier: 04048675407881
• UDI-Public: (01)04048675407881(11)190917(93)8414000-37
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K003068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/16/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown