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

Model Number	8416000
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Deliver (2338); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device was tested onsite by dräger service and the log file was provided for further analysis.The log entries indicate that the device switched off due to a faulty or depleted internal battery.The alarm messages "battery low" and "battery discharged" were being posted by the device, but the time from the alarms until battery depletion was lower than specified.During the device test the device was recharged and the subsequent battery charge-discharge-charge cycle complied with the specification.This can be caused by the device not being operated on internal battery for a longer period of time due to reversible electrochemical effects.A full functional test of the device showed no malfunction.In case of mains power loss or during transport the device will be supplied from the internal battery in order to continue operation.The specified back-up time with a new and fully charged internal battery at typical ventilation is about 30 minutes.Depending on battery capacity and battery voltage further alarm messages ¿battery low¿ and ¿battery depleted¿ are posted with progressive battery operating time.In case battery power depletes, the acoustical power failure alarm will sound according to iec 60601-1-8.This alarm is energized independently from the power supply and will last for at least 2 minutes.The device will stop ventilation by opening the safety valve to ambient allowing the patient for spontaneous breathing.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 that during transport the ventilator shutdown without warning.No 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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 22034271
• Report Number: 9611500-2025-00257
• Device Sequence Number: 13132420
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)170206(93)8416400-16
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 05/16/2025

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: 04/17/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2017
• 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.
• Patient Sex: Unknown