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

Catalog Number 8416000

Device Problems No Display/Image (1183); Failure to Read Input Signal (1581)

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

Event Date 03/07/2024

Event Type  malfunction  

Event Description

It was reported that the ventilator screen turned itself off during use and there was a charred smell.The patient was still ventilated, and sao2 and co2 remained normal.The ventilator screen could not be turned on again and no settings could be changed.

Manufacturer Narrative

The affected device was analyzed onsite by dräger service.Due to the error pattern the logbook was not available.During the analysis a faulty cockpit mainboard and service board was identified as the root cause of the problem.In addition, an error on the solid-state disk was discovered during the analysis.After replacing the faulty parts, the device passed all tests.Based on the analysis the faulty parts led to a permanent malfunction of the cockpit.The ventilator software analyzes and verifies the device is functioning properly.The software has detected an internal error and the user is alerted to this condition with an audible alarm.Ongoing ventilation is not interrupted during the described event.Safety-relevant parameters such as fio2, minute volume or airway pressure, and an indicator for ongoing ventilation are shown in the additional oled display on the ventilation unit.If the cockpit completely loses functionality, the ventilation continues with the last settings.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 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: 19141649
• MDR Text Key: 340805581
• Report Number: 9611500-2024-00169
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)210315(17)220112(93)8416400-21
• 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: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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