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

Catalog Number 8416000

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Reset Problem (3019); Intermittent Communication Failure (4038)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that the ventilator had shut down during use.There was no patient injury reported.The biomed conveyed that when the unit was powered back on the screen displayed "???".

Manufacturer Narrative

The logbook of the affected device was available for the investigation.Based on the logbook entries it was confirm that the device performed a warmstart of the ventilation unit at the date of event as a specified reaction to a detected time-out in the software task processing.After the warmstart, the alarm message "ventilation unit restarted" was generated and the ventilation continued with the last settings.A further analysis revealed that an error in the data processing of the activated co2 measurement was the cause of the error.The error can be prevented by switching off the integrated co2 measurement.The device behaved as specified for the failure by performing a warmstart of the ventilation unit to solve the issue.During the warmstart, the emergency valve is opened to ambient to allow the patient to breathe spontaneously.After a successful restart, the alarm message "ventilation unit restarted" is generated and ventilation is continued with the last settings.The number of similar cases, related to the same root cause, is not within the expected range of the respective risk assessment.A field safety corrective action is currently being planned and will be published shortly to inform the users of this risk.A new software version is currently being developed to solve the issue.

Event Description

It was reported that the ventilator had shut down during use.There was no patient injury reported.The biomed conveyed that when the unit was powered back on the screen displayed "???".

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.

Event Description

It was reported that the ventilator had shut down during use.There was no patient injury reported.The biomed conveyed that when the unit was powered back on the screen displayed.

• Brand Name: INFINITY ACS WORKSTATION CC
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11677577
• MDR Text Key: 248033723
• Report Number: 9611500-2021-00159
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 05/27/2022

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: 03/29/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 07/20/2021; 07/20/2021
• Supplement Dates FDA Received: 08/03/2021; 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2018
• 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