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); Intermittent Communication Failure (4038)

Patient Problem No Consequences Or Impact To Patient (2199)

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 the screen of the workstation went blank and that automatic ventilation stopped.

Manufacturer Narrative

The log file was analyzed for the reported date of event.During the case in question three reboots of the processors onboard the therapy control unit were entered.This kind of reboot incorporates a short-term outage of therapy functions for a maximum of 15 seconds and is accompanied by an alarm before the therapy is resumed with the last valid settings.The therapy control unit was replaced on-site and the device is now back in operation; no further problems reported since then.The replaced therapy control unit was returned to the manufacturer for further investigation and was built into a laboratory device.Several system tests were performed which all were passed successfully.The lab device was ran for 5 days in several different ventilation modes including on/off cycles and parameter changes - however, no reboot has occurred.Despite intensive testing the error condition could not be duplicated.The conditions that triggered the processor reboot remain unknown.A reboot is the specified device response to overcome a deviation that cannot be removed by other means.Therapy was resumed with previous settings; no patient consequences have occurred.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that the screen of the workstation went blank and that automatic ventilation stopped.

• 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: 10957632
• MDR Text Key: 219870513
• Report Number: 9611500-2020-00448
• Device Sequence Number: 1
• Product Code: BSZ
• 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: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• 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: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1