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

Catalog Number 8416000

Device Problem No Display/Image (1183)

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

Event Date 03/30/2024

Event Type  malfunction  

Manufacturer Narrative

The log file of the affected device was made available and analyzed.Based on the log file analysis, a communication problem between the cockpit and the ventilation unit could be confirmed on the reported date of event.As a result of the communication problem, the device initiated a restart of the cockpit to remedy the issue.Evaluating the log entries it can be assumed that the cockpit issue persisted between 03.12 a.M.And 03.21 a.M.After 03:21 a.M.The cockpit was functional again until the device was switched to standby mode by the user at 03:38 a.M.As result of the investigation a faulty hard disk drive of the cockpit was identified as root cause of the event.The faulty hard disk drive of the cockpit must be replaced.Other than reported, the main function of the device - the ventilation - was not affected by that issue.The ventilation was continued during the whole time the device was in operation.As a safety feature of the system, the safety software analyzes and verifies proper function of the device.If the safety software detects a deviation concerning the cockpit infinity c500, a restart of the cockpit will be triggered in order to reset the micro processing system to a specified state.The ventilation will not be affected by a restarting cockpit and will be continued as set.Safety relevant parameters are displayed in the supplemental oled-display wherein the user can see the on-going ventilation.Monitoring functions and the user interface of the cockpit are not available during the restart.After successful completion of the cockpit restart, the system will post the alarm message ¿cockpit restarted¿ with accompanying audible alarm tone.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 screen of the device repeatedly went black during the use of the device.When it happened the first time, the patient was still being ventilated and the device reportedly seemed to be operating normal after the screen had come on again.When the screen went black again reportedly two more times, it was reported that the device was not venting the patient during this time and the staff had to bag the patient.The staff were preparing a different ventilator to transfer the patient on to.There were no patient health consequences reported.

• Brand Name: INFINITY ACS WORKSTATION CC
• Type of Device: VENTILATORS, INTENSIVE CARE
• 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: 19141651
• MDR Text Key: 341023534
• Report Number: 9611500-2024-00170
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)170208(93)8416400-16
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/19/2024

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: 8416000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2017
• 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