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 03/03/2021

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 at 3:36 am the ventilator continuously alarmed loudly for approx.3 seconds during normal ventilation.The patient was reportedly not affected by the issue and no injury was reported.

Event Description

It was reported that at 3:36 am the ventilator continuously alarmed loudly for approx.3 seconds during normal ventilation.The patient was reportedly not affected by the issue and no injury was reported.

Manufacturer Narrative

The affected device was examined by dräger service technician onsite and the log file and service report were provided for further investigation at the manufacturer¿s site.The log file analysis showed that the ventilation unit performed a warm start two times during ventilation on the 3rd of march 2021 caused by a temporary time-out in the software task processing.Such a warm start is a specified behavior to reset the micro processing system to a specified state.The ventilation was automatically continued with the latest settings after the warm start had been completed.As per log file the accompanying alarm message «ventilation unit restarted» was posted by the cockpit infinity c500.As a safety feature of the system, the safety software analyses and verifies proper function of the device.If the safety software detects an internal failure concerning the ventilator, a local warm start of the ventilation unit would be triggered, and the emergency-breathing valve would open to ambient allowing the patient for spontaneous breathing.Alarms would be posted in order to alert the user of the situation.The device reacted as specified to a detected temporary deviation and initiated a warm start in order to remedy the issue.The pba m16.2 and the cf card were replaced and the software was reinstalled as a precautionary measure; the device was successfully tested according to the manufacturer's specification and returned back into service.There were no patient health consequences reported.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 23542 ; GM 23542
• MDR Report Key: 11663308
• MDR Text Key: 247526794
• Report Number: 9611500-2021-00155
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)200812(17)201125(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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• 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
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1