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	Low Oxygen Saturation (2477)
Date of Event	11/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient who had a severe accident resulting in coma and significant desaturation was connected to the ventilator but that the users could not establish a sufficient ventilation.The device reportedly posted alarms indicating low airway pressure and insufficient ventilation whereupon the users switched over to manual ventilation first and transferred the patient to another device afterwards.Patient outcome is unknown.As a side note, the user suspected a malfunction of the "oxygen flow sensor".
Additional Manufacturer Narrative
The user facility did not involve the local dräger s&s organization into any follow-up measures.Dräger reached out to the contact person named in the ufr but this person could not provide additional details.This lack of information does not allow a reliable assessment of the reported event and thus, this report is filed in abundance of caution.As per report, the device has alarmed to alert the user about a low airway pressure and an insufficient ventilation; the hospital suspected an issue with the "oxygen flow sensor".Such a sensor does not exist.The device measures the inspiratory oxygen concentration via an oxygen sensor and the expiratory flow with a flow sensor.Gas dosage is controlled by other mechanisms.The expiratory measured flow is a base for the calculation of the expiratory minute volume, and this value is compared to the volume the device has applied during the inspiration phases.A divergence between these values is an indication that a significant portion of the inspiratory delivered volume escapes through a leak in the patient circuit to ambient.The aspect in the report that the device has also alarmed for low airway pressure is another indication for the presence of a leak - the device was not able to build up a sufficient airway pressure to apply the set tidal volumes.All types of alarms, potential root causes and dedicated remedies are listed in the ifu.Finally, it cannot be concluded due to lack of relevant information if the reported event was solely related to the critical condition of the patient, if indeed a malfunction was present that has contributed to the event or if use error was a considerable factor.It is recommended to the hospital to have the device checked by trained service personnel.

• 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: 20899765
• Report Number: 9611500-2024-00554
• Device Sequence Number: 5092534
• Product Code: CBK
• UDI-Device Identifier: 04048675407881
• UDI-Public: (01)04048675407881(11)170418(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): 12/11/2024

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?: 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: 11/26/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2017
• 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