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

Catalog Number 10-134

Device Problem No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The responsible dräger service engineer could confirm the reported issue during on-site checking and trace it back to the ventilator motor.The entire motor assembly was replaced, consequently.Also the evaluation of the log file confirms an issue with the ventilator (motor) on the date of event.In case the primus shuts down automatic ventilation, the device will generate an audible alarm and a visible alarm message "ventilator fail" will be displayed.In this case, automatic ventilation is not possible.The user can switch to manual ventilation as described in the instructions for use.Monitoring is still functional.The motor assembly has brushes, ball bearing, commutator disk and a spindle which are affected from aging caused by wearing.The kollmorgen motor assembly, that was installed in the objected device, has been designed for a durability of >10 years (5 hrs/day, 5 days/week, 52 weeks/year, 13000 hours).The involved motor is approx.10 years old and with the 15,277 hours logged, the device reached 117% of the estimated working hours.The replacement of the affected motor assembly by the dräger service engineer has already solved the problem, no patient consequences have reportedly occurred.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 the ventilation failed during operation.No injury reported.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA 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: 9443668
• MDR Text Key: 186753448
• Report Number: 9611500-2019-00422
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10-134
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2009
• 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