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

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 05/20/2021

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 primus displayed the message "ventilator failure" at the end of an anesthesia at approximately (b)(6) 2021.No patient injury was reported.

Event Description

It was reported that the primus displayed the message "ventilator failure" at the end of an anesthesia at approximately 4:40 pm on (b)(6) 2021.No patient injury was reported.

Manufacturer Narrative

The logbook provided was analyzed for the investigation.The described issue could be confirmed and no indications for a technical device malfunction were found.The case in question was started on (b)(6) 2021 at 4:38 pm in pressure mode.The following ventilation was accompanied by a permanent lack of fresh gas from the beginning, the device alerted accordingly.The flow measurement detected mv leaks of up to 3.1 l/min.As a result, there were strongly fluctuating pressure conditions with pronounced negative as well as positive pressure peaks.The device consequently alerted both aw.Pressure high as well as pressure negative.At 4:41 pm, a blockage of the piston occurred as a result of an unexpectedly rapid increase in pressure, whereupon the ventilator initiated an automatic shutdown as well as the autonomous switchover to man/spont.At the same time, ventilator failure was alerted.Ventilation continued in manual mode and was terminated at 4:54 pm with a switch to standby.Root cause for the reported symptom was an overpressure at the patient end of the circuit leading to a pressure peak.Most likely, the unstable pressure situation was the result of the patient breathing or coughing against the ventilator.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 responded as specified upon the detected situation with an autonomous shutdown while changing mode to man/spont (safety mode) accompanied by an audible and visible "ventilator fail" alarm.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

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.

Event Description

It was reported that the primus displayed the message "ventilator failure" at the end of an anesthesia at approximately 4:40 pm on (b)(6)2021.No patient injury was reported.

• Brand Name: PRIMUS
• Type of Device: ANESHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11928795
• MDR Text Key: 257704299
• Report Number: 9611500-2021-00237
• 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,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• 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: 06/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2008
• 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