MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION NC; VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC

Model Number	8415000
Medical Device Problem Codes	No Display/Image (1183); Failure to Read Input Signal (1581); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported by the user: patient was being transferred onto device when it switched off.Battery fully charged and plugged into mains at the time.Replacement device found.Machine was then switched back on, the ventilation worked but the screen was blank.No harm to patient.
Additional Manufacturer Narrative
The log file of the affected device was analysed regarding the reported event.Based on the analysis of the log file, the reported device shutdown could not be confirmed.The investigation revealed a temporary failure of the display.The ongoing ventilation was not affected and continued as set.The ssd and the bios battery were replaced by the dräger service as preventive measures.The device was tested and confirmed to be operating as per manufacturer¿s specification.In case of a display malfunction, monitoring functions and the user interface of the cockpit are not available.The running ventilation is not affected by such an issue and continues as previously set.Safety relevant parameters as fio2, minute volume, or airway pressure are displayed in the supplemental oled-display and the user can see the on-going ventilation.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported by the user: patient was being transferred onto device when it switched off.Battery fully charged and plugged into mains at the time.Replacement device found.Machine was then switched back on, the ventilation worked but the screen was blank.No harm to patient.

• Brand Name: INFINITY ACS WORKSTATION NC
• Common Device Name: VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC
• 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: 24331164
• Report Number: 9611500-2026-00056
• Device Sequence Number: 18580557
• Product Code: CBK
• UDI-Device Identifier: 04048675250418
• UDI-Public: (01)04048675250418(11)160115(93)8417400-14
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093632
• 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): 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: 8415000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2016
• 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