MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PERSEUS A500; ANESTHESIA UNITS

Catalog Number MK06000

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); No Pressure (2994); Intermittent Communication Failure (4038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported during a case that the unit alarmed for "pressure sensor failure".The touch screen on the ventilator had frozen, and the unit rebooted within 5 seconds.There was no patient injury reported.

Manufacturer Narrative

A dräger service technician checked the device after the reported event and determined that a reset of the therapy control unit including a reinstallation of the software was necessary.After that the device passed all tests according to dräger specification.The technician downloaded the electronic log file and submitted it for further analysis.Based on the log entries the date of event could be reconstructed.The automatic system test was passed in the morning and the case in question was started at 8:07am.For 4 hours ventilation was stable until 12:07pm when a when the device detected an interruption of the internal communication between the two processors of the therapy control unit.This led to a short processor reset/reboot.After completion of the reset, the device resumed therapy with the last valid settings.The case was continued without any further issues and completed at 2:15pm.As the interruption was of sporadic/isolated nature it couldn¿t be reproduced during device check and the exact root cause couldn¿t be determined.A hardware failure is seen unlikely.The device behaved according to it¿s implemented safety concept as it triggered a reboot and resumed therapy with the last valid settings.Issues in context with the therapy control unit are within an accepted range.

Event Description

It was reported during a case that the unit alarmed for "pressure sensor failure".The touch screen on the ventilator had frozen and the unit rebooted within 5 seconds.There was no patient injury reported.

• Brand Name: PERSEUS A500
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10919345
• MDR Text Key: 218676959
• Report Number: 9611500-2020-00441
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)171026(17)180606(93)MK06000-34
• Combination Product (y/n): N
• PMA/PMN Number: K133886
• 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: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MK06000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1