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

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Output Problem (3005); Activation Failure (3270)

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

Event Date 04/06/2022

Event Type  malfunction  

Event Description

It was reported that during the running condition suddenly machine gives alarm of gas mixer after that it shows ventilator fail alarm.Machine stopped the ventilation.

Manufacturer Narrative

The investigtion was just started, the result will be forwarded after closing the investigation.

Event Description

It was reported that during the running condition suddenly machine gives alarm of gas mixer after that it shows ventilator fail alarm.Machine stopped the ventilation.

Manufacturer Narrative

For the investigation the provided logfile was analysed.Other than initally reported it was not possible to retrace a failure of the ventilator during use on a patient.The logfile showed that the device was powered on for four times on the reported date of event and each time it was immediately alarmed with "ventilator fail", it was obvious to the user that the device was not ready for operation.In general, in case of a ventilator failure the device alarms optical and acoustical and switches to monitoring mode, manual ventilation remains available.It was not possible to clarify the root cause in detail, however it was recommended to check the ventilator motor.No furhter probems were reported since then.The device has recognized the device status before use on a patient during power on self test in accordance with the specifications and indicated it optically and acoustically.

• 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: 14236305
• MDR Text Key: 297349373
• Report Number: 9611500-2022-00106
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• 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: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2013
• 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