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

Catalog Number MK06000

Device Problems Decrease in Pressure (1490); Failure to Deliver (2338); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Results will be provided in a separate follow-up report.

Event Description

It was reported that the performance of the graphical user interface was restricted.Preliminary analysis of the electronic log file revealed that the device performed a warmstart.There was no injury reported.

Manufacturer Narrative

The examination was carried out based on the device logbook analysis as well as a laboratory examination in which the configuration at the customer's site was recreated.It was found that the reported symptoms were caused by differently adjusted baud rates at the icm/digibox input and the perseus.As a result, commands in the perseus are not interpreted correctly.In particular, package end characters are no longer recognized, so that the perseus data buffer grows continuously, and the processor load gradually increases.If due to this other processes are blocked, finally a reset is triggered.This leads to a therapy interruption of maximal 15 seconds.The therapy is then continued with the last valid settings.As initially reported, a slowed display of the real-time curves and a short-term delayed reaction during selection and confirmation of therapy settings could also be observed in the laboratory test in the run-up to the resets.The logbook also contains indications of increased processor workload as well as reboots.After adjusting the baud rate, the problem was fixed.In the already available sw version 2.03, the size of data packets in the medibus buffer is limited to avoid processor overload.In this way, the problem will be prevented in the future even if the baud rates are set differently.The distribution of the sw 2.03 will be carried out with a field safety corrective action.All devices equipped with sw versions 2.01 and 2.02 will be upgraded to sw2.03.

Event Description

Please refer to the initial report.

• 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: 10037570
• MDR Text Key: 190287428
• Report Number: 9611500-2020-00145
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

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: Not provided
• Initial Date FDA Received: 05/08/2020
• Supplement Dates Manufacturer Received: 06/09/2020
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1