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

Catalog Number 8416400

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2023

Event Type  malfunction  

Manufacturer Narrative

The provided log file of the affected device was analysed regarding the reported event.Based on the analysis of the log file the reported event could be confirmed.The log file revealed two restarts of the ventilation unit for unknown reason.Since the internal communication could not be reset within expected time in the course of the restart sequence, the alarm message device failure (3) was posted.As a safety feature of the system, the safety software analyses and verifies proper function of the device.If the safety software detects an internal failure concerning the ventilator, a restart of the ventilation unit will be triggered with accompanying alarm.The restart sequence lasts for a maximum of 8 seconds.During that time the emergency-breathing valve remains open to ambient allowing for spontaneous breathing.After successful restart the ventilation will be automatically resumed and continued with the latest settings.If the internal communication between the cockpit and the ventilation unit cannot be reset within expected time, the alarm message "device failure (3)" will be posted.The display of monitoring parameters on the cockpit screen might be restricted in case of present "device failure (3)".Safety relevant parameters as fio2, minute volume, or airway pressure are displayed in the supplemental oled-display wherein the user can track the on-going ventilation.The device reacted as specified to the detected deviation.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 Description

It was reported that the device displayed an ¿device failure (3)¿ during use on a patient.No health consequences for the patient were reported.

• Brand Name: INFINITY ACS WORKSTATION CC
• Type of Device: 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: 18533072
• MDR Text Key: 333086882
• Report Number: 9611500-2024-00020
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K093633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 8416400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1