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)

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

Event Date 02/14/2021

Event Type  malfunction  

Manufacturer Narrative

The reported event was investigated based on the log file.Based on this the event could be confirmed.A restart of the cockpit (display unit) could not be confirmed with this data.Besides, a faulty flow sensor could be seen in the relevant log files.However, the software requested a restart of the ventilation unit.The event was caused by a temporary timeout in the processing of software tasks.The security software monitors the proper functioning of the device.If such deviation is detected, the device generates a corresponding acoustic and visual alarm, and initiates a restart of the ventilation unit to solve the issue.During the restart the emergency ventilation valve would open to the environment and allow the patient to breathe spontaneously.After a single restart the issue was solved, and the ventilation continued with the previous settings.The software was reinstalled as a precautionary measure and the faulty flow sensor has been replaced.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 during use the ventilator alarmed for both a ventilator restart and an incompatible flow sensor.There was no patient injury reported.The device file was provided to the dräger technical support team for evaluation and recommendations.The reported issue was verified and it was recommendations were provided.The biomed ran the unit for an extended without any errors.The unit was released for use with out further issue.

• 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: 11459735
• MDR Text Key: 244676865
• Report Number: 9611500-2021-00100
• 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: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/11/2021

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: 02/27/2021
• Initial Date FDA Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2012
• 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