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

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Failure to Sense (1559); Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that the device alarmed "ventilator failure" during anesthesia.No injury reported.

Event Description

It was reported that the device alarmed "ventilator failure" during anesthesia.No injury reported.

Manufacturer Narrative

The electronic logfile was available for investigation.The reported event could be reconstructed by means of the information stored therein.During the case in question, the primus detected that the vacuum pressure went out of range.As per specification, the device forced a shutdown of automatic ventilation and posted the corresponding vent fail alarm.The log indicates that the user completed the procedure in manual ventilation.It can be concluded that a failure of the pressure sensor that monitors the auxiliary vacuum pressure has caused the system response.Dräger finally concludes that the device reacted as designed.No patient consequences have occurred; 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: 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
• MDR Report Key: 12717823
• MDR Text Key: 280877510
• Report Number: 9611500-2021-00443
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• 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: 10/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2006
• 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