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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2023

Event Type  malfunction  

Event Description

It was reported that during operation the message "ventilator failure" was displayed on the primus towards the end of an operation.The operation was completed by means of manual ventilation.No injury was reported.

Manufacturer Narrative

The investigation was just started, the result will be forwarded after the investigation was closed.H3 other text : on-going.

Manufacturer Narrative

Based on the analysis of the device logfile, the case could be reconstructed.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 replacement of the motor assembly has already solved the problem.After replacement, the device passed testing and was returned back to use with no further problems reported.

Event Description

It was reported that during operation the message "ventilator failure" was displayed on the primus towards the end of an operation.The operation was completed by means of manual ventilation.No injury was reported.

Manufacturer Narrative

Based on the analysis of the device logfile, the case could be reconstructed.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 replacement of the motor assembly has already solved the problem.After replacement, the device passed testing and was returned back to use with no further problems reported.

Event Description

It was reported that during operation the message "ventilator failure" was displayed on the primus towards the end of an operation.The operation was completed by means of manual ventilation.No injury was reported.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 17955081
• MDR Text Key: 326059521
• Report Number: 9611500-2023-00367
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• 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?: No
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2005
• 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