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

Model Number	8414000
Medical Device Problem Codes	Gas Output Problem (1266); Decreased Pump Speed (1500); Failure to Deliver (2338)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	05/07/2024
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 the ventilator failed during ventilation and displayed the error code 42.0002.The nurse immediately replaced the ventilator.The patient¿s oxygen saturation temporarily decreased but stabilized after replacement of the ventilator.No further patient health consequences were reported.
Event or Problem Description
It was reported that the ventilator failed during ventilation and displayed the error code 42.0002.The nurse immediately replaced the ventilator.The patient¿s oxygen saturation temporarily decreased but stabilized after replacement of the ventilator.No further patient health consequences were reported.
Additional Manufacturer Narrative
The investigation was based on the initially reported information.The user facility did not involve the local dräger service organization into on-site examination of the device.No further information or log file was provided for analysis.The reported error code 42.0002 indicates a deviation regarding the turbine speed and is audibly and visibly alarmed with high priority.The deviation regarding the turbine speed can either be of a minor temporary nature without an effect on the ventilation or can affect the ventilation by causing a restart or interruption of the ventilation.During a restart procedure, the device would alarm, and the pneumatic system would open which reduces airway pressure to ambient pressure and spontaneous breathing is possible for the patient.As no further information was available, neither the effect of the error code nor the root cause for the error code could be determined.The device reacted as specified on a detected deviation regarding the turbine speed and posted corresponding alarm messages.The user decided to replace the device in a controlled maneuver and apart from a temporarily decreased oxy saturation no serious patient consequences have occurred.The investigation did not reveal any new risks which are not covered by the product risk management.

• 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: 19390332
• Report Number: 9611500-2024-00229
• Device Sequence Number: 7689994
• Product Code: CBK
• UDI-Device Identifier: 04048675407881
• UDI-Public: (01)04048675407881(11)220110(93)8414000-38
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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
• Device Catalogue 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: 05/07/2024
• Supplement Date Received by Manufacturer: 07/07/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2022
• 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