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

Catalog Number 8416400

Device Problems Complete Blockage (1094); Gas Output Problem (1266); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 02/04/2021

Event Type  Death  

Manufacturer Narrative

The investigation has been started.Unfortunately the logbook of the affected device have not yet been made available to the manufacturer.Therefore the information for investigation is very limited.Investigation results will be provide in a final report.

Event Description

The customer reported that a patient died during the ventilation.The log file showed that exp.Resistance high were frequently recorded.

Manufacturer Narrative

The investigation was based on the reported event, correspondence and enhanced information.The logbook was sent later.The case was initially reported to the appropriate authorities because an adverse event with cause of death of a covid patient was notified.The analysis of the provided log file has shown that the ventilation was started on (b)(6) 2021 at 1:23 pm.On (b)(6) 2021 at 8:58 pm the device posted during the evening several alarm messages concerning "peep high" and "peep low".The user started several suction maneuvers at 9:07 pm, 10:47 pm, 11:27 pm, 11:35 pm and 11:43 pm.At 11:55 pm the user switched the device into standby mode.The log file confirmed peep related alarms on the date of event.A high peep could cause e.G.By the patient condition or obstructions in breathing circuit (blocked filter or fluid in breathing circuit).Fluid in breathing circuit corresponds with the several suction maneuvers which were performed on (b)(6) 2021.The device reacted like specified to a detected difference between the set and measured peep and posted accompanying alarm messages.The log file analysis did not reveal a device malfunction.As a safety feature of the system, the safety software analyses and verifies proper function of the device.If the safety software detects high peep audible alarms would be posted to inform the user about the problem.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.

Event Description

The customer reported that a patient died during the ventilation.The log file showed that exp.Resistance high were frequently recorded.

• 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
• MDR Report Key: 11320525
• MDR Text Key: 231561209
• Report Number: 9611500-2021-00059
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8416400
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death