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

Patient Problem No Consequences Or Impact To Patient (2199)

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 device performed a restart during use.There was no patient injury reported.

Event Description

Please refer to the initial report.

Manufacturer Narrative

The reported symptom could be reconstructed by means of the information stored in the log.The case in question was started at 8:25am system time.At 10:28am, the supervisor software triggered a reboot of the entire device due to the fact that a communication interruption between the pcb, that controls the therapy functions, and the user interface (display and touchscreen) was detected.In case of such a reset, therapy will be interrupted for approximately 15 seconds.Afterwards, therapy will be continued with the last valid settings.Also in the particular case, the device behaved as specified after the reset.However, it was found in the logfile that the device was switched to standby mode after the reset.A system test was performed, passed and the case in question was continued without any further problems until finishing the case at 4:37pm.The affected pcb was replaced on-site and returned to the manufacturer for analysis.The board was built into a test device and two comparable reboots could be reproduced.Even though no indications for a hardware failure were found in the course of further functional testing, it can be concluded that the replaced pcb was the root cause for the reported symptom.The replacement of the pcb on-site has already solved the problem, no further problems have been reported; no patient consequences have reportedly occurred.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• 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: 10068638
• MDR Text Key: 191574624
• Report Number: 9611500-2020-00164
• 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: 06/23/2020

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: 04/23/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 06/15/2020
• Supplement Dates FDA Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1