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

Catalog Number 8607500

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Inaccurate Delivery (2339); No Pressure (2994); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow up-report.

Event Description

It was reported that the device had a ventilator failure during use.There was no patient injury reported.

Manufacturer Narrative

The ventilator failure described by the user could be reconstructed by means of the logfile analysis.No indications for a device malfunction were found.The autonomous safety shutdown of the ventilator was triggered by a faulty motor position as a result of frequently changing positive and negative pressure peaks, possibly due to the patient breathing or coughing against the ventilator.At the time in question, pressure control ventilation was used; in general, it is recommended to switch on the synchronization for spontaneously breathing patients (e.G.Pressure mode with activated trigger) or use synchronized ventilation mode (e.G.Pressure support).The device behaved as specified with an autonomous shutdown while changing mode to man/spont (safety mode) accompanied by an audible and visible "ventilator fail" alarm.In advance, the user was informed about the fresh gas deficiency and pressure situation (alarms fg low or leak/apnea/aw.Pressure high).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

Please refer to the initial-report.

Event Description

Please refer to initial mfr.Report.

Manufacturer Narrative

Initial analysis of the reported observations led to the conclusion that a causal connection to the controller board of the device is likely.The particular pcb was replaced, the device passed all consecutive tests and is back in use w/o further problems reported since then.The error condition could be provoked in the lab with a specific software which generates a multitude of read-write-operations between the main processor and a dedicated memory chip.One single reboot was the only consequence if the triggering conditions came into effect.A deviation in the electronic system that can't be rectified by sw routines will trigger a restart of the entire system.During the restart sequence which usually does not take longer than 12 seconds the device opens the pneumatic system to ambient to enable spontaneous breathing of the patient.The user will be alerted by means of a corresponding high-priority alarm.After completion of the restart the ventilation will be continued with the last valid settings.The error condition could only be duplicated under exacerbated test conditions i.E.The occurrence rate in the field will be much less in comparison to the conditions used in the lab tests.Investigation of the issue is still ongoing to understand the problem in full level of detail and to define measures that suppress the triggering conditions for the reported single reboots.

Event Description

Please refer to the initial-report.

Manufacturer Narrative

The follow-up report #2 was inadvertently sent under this mdr report no.Therefore, please disregard the follow-up report #2.Follow-up report #1 is still valid and contains our conclusions regarding this case.

• Brand Name: PRIMUS IE
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9289377
• MDR Text Key: 180402506
• Report Number: 9611500-2019-00370
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607500
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1