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

Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2019

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 stopped ventilating during use.There was no patient injury reported.

Manufacturer Narrative

A dräger service engineer was examining the device on-site.The reported issue of ventilator failure could be confirmed; the entire motor assembly was replaced which has put back the device into fully operable condition.The log file evaluation provided by the manufacturer confirms the results obtained on-site.The issue is known from earlier reported instances of the same nature.Root cause for the ventilator failure is wear and tear at the collector disc of the motor which led to partly disrupted electrical contact to the carbon brushes resulting in fluctuations in rotating speed.The supervisor function of the device monitors the motor speed continuously and compares the expected piston position with the one derived by the encoder check.If deviations are detected the device will force a shutdown of automatic ventilation to prevent from damages to the ventilator unit.This is accompanied by a corresponding alarm; manual ventilation as well as the monitoring functions remain available.No patient consequences have occurred and dräger finally concludes that the primus workstation responded as designed upon the malfunction of a single component that became worn after approx.Ten years of operation which matches the specified lifetime.The use model for calculation (5 hours/day & 5 days per week) equals to 13.000 hours in ten years while the operation hours counter for particular motor indicates that it was run for 13.200 hours - 101% of the specified lifetime.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 initial report #9611500-2019-00411.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9415358
• MDR Text Key: 184742058
• Report Number: 9611500-2019-00411
• 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
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1