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

Model Number	8414450
Medical Device Problem Codes	Device Alarm System (1012); Device Difficult to Program or Calibrate (1496); No Fail-Safe Mechanism (2990)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.
Event or Problem Description
It was reported that during ventilation of a patient with chronic obstructive pulmonary disease the device displayed the alarm message "device failure 54.0001".Reportedly, the user was unable to eliminate the alarm and the device could not be used.The device was replaced.It was reported that the patient's body function and the patient's treatment process were impaired.
Additional Manufacturer Narrative
The affected device was examined onsite by the dräger service and the log file was provided for further investigation.Based on the analysis of the log file the reported device failure 54.0001 could be confirmed.The device failure 54.0001 indicates a deviation of the auxiliary alarm system.This system is automatically and periodically tested by the safety software of the device.In case of a detected deviation, the corresponding alarm will be raised.The ventilation and monitoring functions of the device are not affected by this issue and continue as set.The device reacted as specified to the detected deviation.The faulty components were replaced by the dräger service, and the device was tested and confirmed to be operating as per manufacturer´s specification.Based on the available information, we do not consider the case to be reportable, as neither a death nor a serious deterioration in the patient's state of health occurred and this is not to be expected in the event of a recurrence.
Event or Problem Description
It was reported that during ventilation of a patient with chronic obstructive pulmonary disease the device displayed the alarm message "device failure 54.0001".Reportedly, the user was unable to eliminate the alarm and the device could not be used.The device was replaced.It was reported that the patient's body function and the patient's treatment process were impaired.Additional information: other than initially reported, it was determined during further communication with the customer that the reported event caused no health consequences to the patient.

• 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: 19201071
• Report Number: 9611500-2024-00185
• Device Sequence Number: 18124573
• Product Code: CBK
• UDI-Device Identifier: 04048675016403
• UDI-Public: (01)04048675016403(11)230117(17)250701(93)8414450-50
• 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): 06/24/2024

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: 8414450
• Device Catalogue Number: 8414450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• 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: Other
• Patient Sex: Unknown