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

Catalog Number MK06000

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); No Pressure (2994); Intermittent Communication Failure (4038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use on patient the display of the device went off unexpectedly and that the ventilation stopped.No injury reported.

Manufacturer Narrative

The investigation was based on log file analysis.It could be revealed that the workstation passed the system test in the morning of the date of event w/o deviations.The case in question was started at 09:17am system time.At 02:10pm the supervisor software triggered a reboot of the entire device due to the fact that a communication interrupt between the pcb that controls the therapy functions and the user interface (display and touchscreen) was detected.The system resumed therapy with the latest valid settings within 15 seconds after the reboot.From 02:13pm the patient was manually ventilated using man/spont.At 02:19pm the unit was placed into standby, finally.The device is back in use w/o further problems reported since then.It could finally not be determined under which exact circumstances the communication interrupt between the two functional units occurred.A persistent error condition can be excluded since the device is back in use.A reasonable explanation would be that electrostatic discharge or any other electromagnetic disturbance may have caused the phenomenon.This kind of events usually leaves no footprints in the log file as long as it does not lead to destroying of an electronic part.A reliable conclusion in regard to the root cause is however not possible.

Event Description

Please refer to initial mfr.Report #9611500-2019-00441.

• 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: 9479560
• MDR Text Key: 183757796
• Report Number: 9611500-2019-00441
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)170728(17)180324(93)MK06000-33
• 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: 03/20/2020

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: MK06000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 03/18/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1