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

Model Number	8415000
Medical Device Problem Codes	Human-Device Interface Problem (2949); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility report to the national authority is the only source of information.There was no involvement of dräger sales & service into the repair or any follow-up measures after the event - no further information could be obtained.The given information does not allow a case-specific valuation.The extent to which the touchscreen was misaligned or inoperable could not be determined.The root cause can be related to technical issues, mechanical damage or other factors.It can further not be excluded that a recalibration of the touch screen could have solved the issue.However, due to a lack of information, a differentiation is not possible.An impaired or lost touch screen function is obvious for the user and has no effect on the ongoing ventilation.Interaction with the device for e.G.Changing the ventilation parameters may be restricted.Since there are no more information available, a more in-depth investigation is not considered necessary.
Event or Problem Description
It was reported that "the touchscreen malfunctioned during machine operation, making it impossible to adjust parameters." there was neither an indication for a patient involvement nor an injury or health impairment in the report.

• 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: 25134642
• Report Number: 9611500-2026-00205
• Device Sequence Number: 9453305
• Product Code: CBK
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)200211(93)MK06000-38
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2020
• 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
• Patient Sex: Unknown