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

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Failure to Analyze Signal (1539); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device alarmed and ceased automatic ventilation during a surgical procedure.There was no injury reported.

Event Description

It was reported that the device alarmed and ceased automatic ventilation during a surgical procedure.There was no injury reported.The device was involved in an event of identical nature occurred on (b)(6) 2020 which was reported by dräger to fda within the frame of mdr #9611500-2020-003xx.The first notification about the two events was received by dräger after occurrence of the second one.

Manufacturer Narrative

A dräger service engineer was dispatched after the second event.The second shut-down of automatic ventilation could be confirmed upon review of the logs.Due to the fact that the device had been further used after the first event, the entries for the period of first occurrence were overwritten with newer data already.The ventilator motor of the device was replaced.The device passed the consecutive tests and was returned to use.The replaced motor was returned to the manufacturer for evaluation.Visual inspection revealed noticeable amounts of debris on certain surfaces which could be identified as abrasion from the carbon brushes.After installation into a lab device the motor performed as expected and did not exhibit any malfunction.Hence, a reliable conclusion in regard to exact root cause for the two shut-downs of ventilation can't be made.A reasonable explanation however would be that the wear debris from the carbon brushes has sporadically disturbed the performance of the optical detection system for the motor position.The device is designed to shut down automatic ventilation if the motor position detection fails to protect from serious mechanical damages to the ventilator unit.

• 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: 10578832
• MDR Text Key: 208304882
• Report Number: 9611500-2020-00333
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• 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: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1