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

Model Number	8417400
Medical Device Problem Codes	Complete Blockage (1094); Gas Output Problem (1266); Failure to Deliver (2338); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device failed while being used on a patient.An error messages was display on the screen.There were no health consequences for the patient reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the device failed while being used on a patient.An error messages was display on the screen.There were no health consequences for the patient reported.
Additional Manufacturer Narrative
Remark: the initial report was falsely filed for the fabius plus xl.The affected device is the infinity acs workstation nc, serial no.(b)(6).The corresponding fields have been changed accordingly.The log file of the affected device was analysed regarding the reported event.Based on the log file analysis the reported event could be confirmed.The log file revealed that the safety software of the device detected an implausible difference between expiratory and inspiratory pressure.Consequently, the alarm messages ¿device failure¿, "airway pressure low" and "pressure measurement inaccurate" were issued and the device performed a pressure release.Later the device was switched into standby mode by the user.This situation corresponds with fluid in breathing circuit.The measurement of the inspiratory and expiratory pressure is being used for control and monitoring of the ventilation.In case the measurements are implausible adequate alarm messages will be posted to inform the user.In case of a complete loss of function, the emergency-breathing valve would open to ambient allowing for spontaneous breathing.Corresponding visual and acoustical alarms will be activated.However, manual ventilation with an alternate device may be considered necessary.The device reacted as specified to a significant difference between expiratory and inspiratory pressure with an accompanying alarm message and a pressure release of the pneumatic system.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• 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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 20961881
• Report Number: 9611500-2024-00579
• Device Sequence Number: 15365337
• Product Code: CBK
• UDI-Device Identifier: 04048675250418
• UDI-Public: (01)04048675250418(11)170829(93)8417400-16
• Combination Product (Y/N): N
• 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): 02/06/2025

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: 8417400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2017
• 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
• Patient Sex: Unknown