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

Catalog Number MK06000

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Reset Problem (3019); Intermittent Communication Failure (4038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation was just started.The results will be forwarded in a follow up report.

Event Description

It was reported that while a patient was connected to the machine, the screen from a500 turned white for 30 seconds and got back to normal after.No injury reported.

Event Description

It was reported that while a patient was connected to the machine, the screen from a500 turned white for 30 seconds and got back to normal after.No injury reported.

Manufacturer Narrative

The electronic device log file was provided for investigation.The reported observation can be generally confirmed: the device had performed a system reboot during the procedure in question and resumed ventilation after 13 seconds.Since the special signature of the logged error codes point to a malfunction of the subsystem "therapy control unit, a replacement of the particular pcb was recommended as a precautionary measure despite the error condition was of temporary nature only.A reboot of the processors onboard the therapy control unit would incorporate a short-term outage of therapy functions for a maximum of 15 seconds.This will be brought to the operator's attention by corresponding alarms.After resuming processor operation, the therapy will be continued with the previous settings.No patient consequences have been reported for the particular therapy episode.Currently there is no indication for a trend in reboot failures for this type of board in the field.The evaluation of the previously reported instances has not produced any clear finding in regard to the condition that triggered the processor reboot.Dräger finally concludes that the workstation has responded to the malfunction of a single component/subsystem as designed: a reboot was performed to overcome the error condition and the appropriate alarm was posted.

• Brand Name: PERSEUS A500
• Type of Device: ANESHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11331708
• MDR Text Key: 246315357
• Report Number: 9611500-2021-00068
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)191115(17)200625(93)MK06000-38
• 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: 03/23/2021

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: 01/27/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1