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

Catalog Number 8607500

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 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that the ventilator failed during operation and only manual ventilation was possible.No injury was reported.

Manufacturer Narrative

The device was subject to an on-site examination in follow-up of the event.The error condition could not be duplicated.Evaluation of the log file revealed that the device passed the power-on self-test in the morning of the date of event without deviations.The concerned procedure went stable and unremarkable for more than 2.5 hours.Towards the end the supervisor function detected a wrong motor position and forced a shut-down of automatic ventilation with switch-over to man/spont.The user continued patient support in manual ventilation for almost half an hour until the procedure was finished.The device is equipped with a piston ventilator which is driven by a motor in left and right rotation via a spindle.The piston hub is a measure for the volume that needs to be applied.To protect from potentially hazardous output it is necessary to monitor motor position, rotation and acceleration continuously.If significant deviations are detected the device is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.It could not be conclusively determined what exactly has caused the deviation between measured and calculated motor position due to the fact that the error condition was not present anymore when the device was tested after the event.A reasonable explanation would be that the optical position detection system was temporarily disturbed by a dust particle.

Event Description

It was reported that the ventilator failed during operation and only manual ventilation was possible.No injury was reported.

• Brand Name: PRIMUS INFINITY EMPOWERED
• Type of Device: ANESHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11192044
• MDR Text Key: 227572625
• Report Number: 9611500-2021-00030
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675224747
• UDI-Public: (01)04048675224747(11)190325(17)190818(93)8607500-52
• 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: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607500
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1