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); Failure to Deliver (2338); Intermittent Communication Failure (4038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2021

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 unit failed during use.There was no patient injury reported.

Manufacturer Narrative

The logfile analysis carried out by the manufacturer revealed that a communication interrupt between the two processors onboard the therapy control unit have occurred during use.The device is designed to trigger a system reboot when such condition occurs.The reboot resulted in a short-term outage of therapy functions for approximately 13 seconds and was accompanied by a corresponding alarm before the therapy was resumed with the last valid settings.The particular procedure was continued for more than 2 hours without further problems and finished by switching the device into standby.Although the source of the deviation can be attributed to the particular pcb, the exact nature of the issue cannot be determined due to its sporadic nature.The number of similar cases, related to the same phenomenon, is within the expected range of the respective risk assessment and thus accepted.The respective board has already been replaced as a precautionary measure; the workstation passed all consecutive tests and was returned to use without further problems reported.

Event Description

It was reported that the unit failed during use.There was no patient injury reported.

• 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: 11292680
• MDR Text Key: 231111302
• Report Number: 9611500-2021-00048
• 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: 03/24/2021

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: 01/21/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1