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

Catalog Number 8603800

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It has been reported that during recovery the device failure alarm "ventilator failure" occurred.The patient apparently coughed against the ventilation.The device was restarted again, but the error persisted.No injury reported.

Manufacturer Narrative

The electronic log file as well as the replaced motor were available for investigation.Based on the information stored in the log, the reported ventilator failure could be reconstructed.A functional test of the motor revealed that it would not start running when connected to power.Further analysis of the motor`s interior has not revealed any finding.After re-assembly the motor was operating properly again.The exact root cause for the motor failure could not be determined.It is seen likely that one of the brushes detached/got hooked up and moved back into it's original position during disassembly.Based on the log entries it could be excluded that the reported caughing of the patient contributed to the event.This case can be considered a single event.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.

Event Description

Please refer to initial report.

• Brand Name: PRIMUS
• Type of Device: ANESHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9479568
• MDR Text Key: 174775516
• Report Number: 9611500-2019-00451
• 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: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• 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: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1