MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION CC; VENTILATORS, INTENSIVE CARE

Catalog Number 8416400

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.

Event Description

It was reported that during use of a ventilator, suddenly the screen no longer displayed.A doctor performed ventilation with bag valve mask, and replaced the device with a spare ventilator.Ventilation operation continued, but the screen was not displayed.Only fio2 and mve were displayed on the ventilator main body, actual measured value was displayed.Screen was not energized.After returning the device, when attempted to restart the device, it did not start because the screen was not energized.There could be some problem between ventilator main body and screen.The device alarmed.Ventilation continued.No patient health consequences have been reported.However, in case the user cannot adapt ventilation parameters due to a device malfunction for a prolonged time, a serious injury cannot be excluded for patients with a serious condition.

Manufacturer Narrative

The investigation was based on the reported event and analysis of enhanced information from dräger service technician.Additionally, the logfile of the affected evita v500 device with product serial no.Asnb-0017was investigated at the manufacturer site in lübeck.According to the logfile entries at the reported time, the reported event could be confirmed.A defective display could be identified as root cause in the onsite repair shop and was replaced.Afterwards the device was tested according to manufacturer specs without further deviations.As a safety feature of the system, the safety software analyzes and verifies proper function of the device.If the safety software detects a deviation concerning the cockpit infinity c500, a warm start of the cockpit will be triggered in order to reset the micro processing system to a specified state.A warm start sequence of the cockpit may last 45 seconds.The ventilation will not be affected by a restarting cockpit and will be continued as set.Safety relevant parameters as fio2, minute volume, or airway pressure are displayed in the supplemental yellow/green oled-display wherein the user can see the on-going ventilation.Monitoring functions and the user interface of the cockpit are not available during the restart.After successful completion of the warm start, the system will post the alarm message ¿cockpit restarted¿ with accompanying audible alarm tone.In case of a faulty display the ventilation is not affected and is continued with unchanged settings.Monitoring functions and the user interface of the cockpit may be impaired.Safety-relevant parameters such as fio2, minute volume, or airway pressure are displayed in the secondary oled display of the ventilator, and the user can observe the ongoing ventilation.The device reacted as specified and notified the user about a detected deviation with accompanied alarms and tried to solve the deviation with a restart of the cockpit.No patient health consequences have been reported.The field failure rate is continuously monitored by the product quality board.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.

Event Description

It was reported that during use of a ventilator, suddenly the screen no longer displayed.A doctor performed ventilation with bag valve mask, and replaced the device with a spare ventilator.Ventilation operation continued, but the screen was not displayed.Only fio2 and mve were displayed on the ventilator main body, actual measured value was displayed.Screen was not energized.After returning the device, when attempted to restart the device, it did not start because the screen was not energized.There could be some problem between ventilator main body and screen.The device alarmed.Ventilation continued.No patient health consequences have been reported.However, in case the user cannot adapt ventilation parameters due to a device malfunction for a prolonged time, a serious injury cannot be excluded for patients with a serious condition.

• Brand Name: INFINITY ACS WORKSTATION CC
• Type of Device: 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: 19161565
• MDR Text Key: 341683707
• Report Number: 9611500-2024-00171
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K093633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/27/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 8416400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 05/24/2024
• Supplement Dates FDA Received: 05/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1