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

Catalog Number 8603800

Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2020

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 the device had a ventilator failure during use.There was no patient injury reported.

Manufacturer Narrative

The responsible dräger service engineer could confirm the reported issue during on-site checking and trace it back to the ventilator motor.The entire motor assembly was replaced, consequently.Also the evaluation of the log file confirms an issue with the ventilator (motor) on the date of event.It was found that the device forced a shutdown of automatic ventilation due to a detected wrong motor position.The motor speed is being monitored continuously; speed fluctuations caused e.G.By an abraded collector disc will result in a deviation between measured and expected piston position.To prevent from damages, the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.Manual ventilation and the monitoring functions remain available to the full extent.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component; no patient consequences have been reported.The repair exchange of the motor unit has fully solved the problem.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that the device had a ventilator failure during use.There was no patient injury reported.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10716794
• MDR Text Key: 212481547
• Report Number: 9611500-2020-00369
• 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,Followup
• Report Date: 11/30/2020

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: 8603800
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1