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

Catalog Number 8603800

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

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

Event Date 01/11/2022

Event Type  malfunction  

Event Description

It was reported that the device failed during anesthesia and generated an error message.No injury reported.

Manufacturer Narrative

The investigation was just started.The result will be forwarded in a follow-up report.

Event Description

It was reported that the device failed during anesthesia and generated an error message.No 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.

• Brand Name: PRIMUS
• Type of Device: ANESHESIA UNITS
• 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
• MDR Report Key: 13364509
• MDR Text Key: 286660250
• Report Number: 9611500-2022-00024
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2007
• 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