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

Catalog Number 8603800

Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation and assessment was based on analysis of the electronic log file.The recorded error codes indicate that the supervisor function detected a wrong motor position and forced a shutdown of automatic ventilation.This detail is in conflict to the user's observation who reported that the problem occurred in manual ventilation mode.The particular device was in operation for 14 years with almost 20.600 hours of runtime logged.The ventilator motor is subject to wear and tear; abrasion at the collector disc is one of the ageing effects that may occur.If there are areas at the circumference of the collector where the electrical contact to the carbon brushes is disrupted due to the abrasion this can have two consequences: the motor will not start up from certain positions and fluctuations in rotating speed may occur which results in a deviation between calculated and real motor position.Scenario a is the more likely one which will lead to an error during self-test i.E.Will be detected prior to use on a patient.Significant fluctuations in rotation speed i.E.A wrong motor position may cause damages to the ventilator unit and thus, the device is designed to force a shutdown of automatic ventilation when the supervisor function detects these deviations during device operation.The shutdown is accompanied by a corresponding alarm to alert the user.Manual ventilation with the built-in breathing bag and the monitoring functions remain available.

Event Description

It was reported that - after switching to manual ventilation mode - ventilation was not possible anymore.No patient consequences have been reported.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA 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: 10137087
• MDR Text Key: 194602275
• Report Number: 9611500-2020-00200
• 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
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• 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
• Date Manufacturer Received: 05/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2006
• 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