MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA V800; ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENT

Model Number	8422500
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Inaccurate Delivery (2339); High Readings (2459)
Health Effect - Clinical Code	Increased Respiratory Rate (2486)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an unexpected auto-triggering of the device occurred with an invasively ventilated patient in neo mode.With a set respiratory rate of 18, the patient's respiratory rate increased to frequencies above 60 despite deep sedation.Reportedly, there was no alarm on the device.This behavior led to a significant deterioration in the patient's condition.The neoflow sensor was replaced.The problem then no longer occurred.Medication was administered to stabilize the patient.
Additional Manufacturer Narrative
The investigation was started; the results will be provided in a follow-up report.
Additional Manufacturer Narrative
The log file of the affected device was made available and analyzed.Furthermore, the neonatal flow sensor insert used was returned for the investigation.The log file analysis showed that the alarm message 'respiratory rate high' was issued several times during (b)(6) 2025.On the same day at 1:02 pm, the alarm limit for the respiratory rate was increased from 60 to 74 per minute.At the reported time of the event (0:30 a.M., september 25, 2025), no alarms were issued regarding a respiratory rate that was too high; the respiratory rate was obviously below the alarm limit set by the user.The log file also shows that the manual calibration of the neonatal flow sensor was last performed on (b)(6) 2025.The examination of the returned neonatal flow sensor insert confirmed that it was fully functional.However, the visual inspection revealed that the retaining clip of the flow sensor insert was bent.A bent retaining clip can, for example, lead to a loose contact between the neonatal flow sensor cable and the flow sensor insert.Since the measured expiratory flow is used to detect spontaneous breathing, such a loose contact can lead to auto-triggering.In addition, a non-calibrated neonatal flow sensor can cause deviations in the minute and tidal volumes and/or auto-triggering.As a safety feature of the system, the safety software analyses and verifies proper function of the device.If the safety software detects that the set alarm limits for ventilation-relevant parameters have been exceeded or not reached, visual alarm messages are displayed on the screen and audible alarms are emitted to inform the user.Proper replacement of the flow sensor insert is described in the instructions for use of the device.In addition, according to the instructions for use, the flow sensors must be visually inspected before use and replaced if damaged.The instructions for use also specify a manual calibration of the neonatal flow sensor at least once a day.Based on the investigation results, it was concluded that the reported event was caused by non-compliant use of the device with respect to the instructions for use (calibration, handling of the neonatal flow sensor).In the current event, the device reacted as specified and generated ventilation-related alarms.A device malfunction could not be identified.After the event, the device was successfully checked in accordance with the manufacturer's specification.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.
Event or Problem Description
It was reported that an unexpected auto-triggering of the device occurred with an invasively ventilated patient in neo mode.With a set respiratory rate of 18, the patient's respiratory rate increased to frequencies above 60 despite deep sedation.Reportedly, there was no alarm on the device.This behavior led to a significant deterioration in the patient's condition.The neoflow sensor was replaced.The problem then no longer occurred.Medication was administered to stabilize the patient.

• Brand Name: EVITA V800
• Common Device Name: ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENT
• 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: 23189927
• Report Number: 9611500-2025-00554
• Device Sequence Number: 18428515
• Product Code: CBK
• UDI-Device Identifier: 04048675542148
• UDI-Public: (01)04048675542148(11)241213(93)8422500-08
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: Z120301
• 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,Followup
• Report Date (Section B): 11/27/2025

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: 8422500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2024
• 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