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 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 stopped ventilating 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.Unfortunately, neither the replaced parts nor the logfile were available for in-depth investigation.According to the reported error code 14.1499, the device forced a shutdown of automatic ventilation due to a detected wrong motor position.The motor speed is 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 by means of a corresponding alarm.Manual ventilation and the monitoring functions remain available to the full extent.Dräger finally concludes based on the investigation, 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 device problem.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that the device stopped ventilating 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: 9909457
• MDR Text Key: 185914023
• Report Number: 9611500-2020-00106
• 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: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• 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
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1