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

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Failure to Analyze Signal (1539); Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation was just started.The results will be provided in a follow up report.

Event Description

It was reported that on monday, aug 23 the error message "ventilation failure" popped up in red during use.They moved to manual ventilation.No injury reported.

Event Description

It was reported that on monday, aug 23 the error message "ventilation failure" popped up in red during use.They moved to manual ventilation.No injury reported.

Manufacturer Narrative

Based on the available log file, the reported case could be reconstructed.It was found that during the case in question, a sporadic failure of the inspiratory pressure sensor of the vgc (ventilation and gas controller) was detected by the device.In consequence, the ventilator initiated an autonomous shutdown while changing mode (pressure mode) to man/spont accompanied by the corresponding "ventilator fail" alarm as specified.In this case, manual ventilation as well as monitoring function remains unaffected.After the case in question, the device was rebooted and passed the power-on self-test.The device was returned to use with no further problems reported.Dräger finally concludes that the device reacted as specified upon a sporadic failure of the inspiratory pressure sensor.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that on monday, (b)(6) the error message "ventilation failure" popped up in red during use.They moved to manual ventilation.No injury reported.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.

• 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: 12445259
• MDR Text Key: 271893077
• Report Number: 9611500-2021-00376
• 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,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• 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: 09/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2006
• 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