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

Catalog Number 8416400

Device Problems Gas Output Problem (1266); Inaccurate Delivery (2339); Gas/Air Leak (2946)

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

Event Date 11/29/2023

Event Type  malfunction  

Event Description

It was reported that device failure 6 ocurred during ventilation.The device alarmed.No patient health consequences have been reported.However, the device performed pressure releases - in case the breathing pressure (incl.Peep) drops to ambient, a deterioration in state of health cannot be excluded for patients with difficult lung/ventilation conditions.

Manufacturer Narrative

The investigation was based on the reported event and logfile analysis of the affected device.Additionally, the device was examined onsite by dräger service.The analyses of the provided logfile revealed that the cockpit infinity c500 posted alarm messages concerning "device failure (6)" during the ventilation at the reported time.Furthermore, the alarm messages "airway pressure low" and "mv low" were posted.As per logfile the device stopped the gas delivery and performed a pressure release for spontaneous breathing, which corresponds to the failure of the gas dosage and mixture module.Later the device was set into standby mode by the user.As a safety feature of the system, the safety software analyzes and verifies proper function of the device.In case of a deviation concerning the gas dosage and mixture module the gas delivery stops and the emergency-breathing valve would open to ambient allowing for spontaneous breathing.Audible and visual alarms will be activated in order to inform the user about the problem.It could be confirmed by logfile analyses that the gas dosage and mixture module failed.The service technician identified a faulty m1.3 gas dosage and mixture module and replaced the part.The device reacted like specified posted accompanying alarm messages and opened the safety valve for spontaneous breathing.The dräger service technician tested the device according to the manufacturer's specifications without any deviations.Field quality data are monitored and assessed by the responsible product quality board.The number of malfunctioning regarding this issue reported from the field is within accepted range.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.

• 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: 18951231
• MDR Text Key: 338259220
• Report Number: 9611500-2024-00123
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8416400
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2013
• 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