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

Model Number	8416000
Medical Device Problem Codes	No Display/Image (1183); Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to draeger - the reported issue is that on friday (b)(6) 2026.In the morning while on a patient the unit screen went black.The ventilator stayed running.The swapped the ventilator out.No reported patient injury.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
The analysis of the transmitted information, including the log file, revealed a temporary deviation of the cockpit.Based on the available information the background lightning caused a faulty display illumination.The ventilation unit is not affected and continued.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.Dräger service onsite replacement the lcd with the inverter board.Afterwards the device was successfully tested according to manufacturer specs.The field failure rate is continuously monitored by the product quality board and is accepted.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
The following was reported to draeger - the reported issue is that on friday (b)(6) 2026.In the morning while on a patient the unit screen went black.The ventilator stayed running.The swapped the ventilator out.No reported patient injury.

• Brand Name: INFINITY ACS WORKSTATION CC
• 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 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 24385614
• Report Number: 9611500-2026-00067
• Device Sequence Number: 18768015
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)210223(93)8416400-21
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 8416000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2021
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• 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