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

Model Number	8414000
Medical Device Problem Codes	Human-Device Interface Problem (2949); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the keys of the ventilator were found to be unresponsive and inoperable while being in use on a patient.Reportedly, the ventilation was not affected and continued as set.The device was replaced.There were no health consequences for the patient reported.
Additional Manufacturer Narrative
The user facility did not involve the dräger service into the repair or any follow-up measures.No further information could be obtained.A case specific evaluation is therefore not possible.It is unknown to what extent the keys of the ventilator were unresponsive.Also, there is no information available if a repair or replacement of parts have been performed.The root cause cannot be determined.It is possible to lock the keys of the device by using the lock key.If activated, the screen and keys are locked against unintentional changes.The activation of the lock key is indicated by a yellow led within the key itself.Its function is described in the instruction for use.However, it is unknown if the function was active during the event.In case of a failure of the keys of the device the ventilation mode and ventilation parameters cannot be changed.An ongoing ventilation will not be affected by this failure and will continue with the current parameters.Alarms and ventilation curves will be displayed normally.Reportedly, the ventilation was not affected and continued as set.

• 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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 20677223
• Report Number: 9611500-2024-00507
• Device Sequence Number: 15578335
• Product Code: CBK
• UDI-Device Identifier: 04048675016403
• UDI-Public: (01)04048675016403(11)170925(17)200701(93)8414450-45
• Combination Product (Y/N): N
• PMA/510(K) Number: K003068
• 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): 11/13/2024

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: 8414000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown