MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PRIMUS; ANESTHESIA UNITS

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

No further details about the course of event have been provided upon request - the only information that could be obtained was that the shut-down did not occur in consequence of use of a bronchial suction system and was not caused by spontaneous breathing either.The log file indicates that the power-on self-test was passed w/o deviations in the morning of the date of event.The concerned procedure went stable and uneventful for the first 3 hours 15 minutes.Starting at that point in time the tidal volumes went back from before 450ml to 300ml.The device alarmed for mv low and apnea ventilation - an aspect from which can be concluded that no inspiratory trigger was generated by the patient.The user switched from pressure support mode to pressure mode then.Another 20 minutes later the device started to alarm for fresh gas low or leak; in the following the device detected significant fluctuations in the airway pressure with huge positive and negative pressure spikes which would be typical for the use of a bronchial suction system during running automatic ventilation.The device alarmed repeatedly for airway pressure high.After one minute a transient pressure rise caused a blocking of the ventilator piston upon which the system responded with emergency shut-down of automatic ventilation and generation of a corresponding alarm.Dräger finally concludes that there was no malfunction of the device.The shut-down of automatic ventilation was the system response to fast pressure spikes that were directed against the piston movement.The ventilation was already disturbed for several minutes before the shut-down occurred; appropriate alarms were posted.The triggering condition for the pressure spikes however could not be determined - the most likely theories of a suction maneuver or spontaneous breathing had been denied by the user.Other conditions like application of pressure to the chest would also be feasible but due to missing information, a reliable concusion in regard to the exact root cause is not possible.

Event Description

It was reported that the device shut down automatic ventilation and posted a corresponding alarm.No patient consequences have been reported.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• 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: 10902880
• MDR Text Key: 223621753
• Report Number: 9611500-2020-00434
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2004
• 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