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); No Pressure (2994); Intermittent Communication Failure (4038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

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 device rebooted unexpectedly and started the system test while in use on a patient.There was no patient injury reported.

Manufacturer Narrative

The evaluation and assessment of this case was based on log file analysis.It can be confirmed that the device performed a reboot on the reported date of event at 20:04:19 system time.Other than reported, operation was resumed a few seconds later at 20:04:30.It is furthermore evident that the device was placed into standby mode at 20:06:11 with switchover to test mode three seconds later.The device is designed to perform a system reboot whenever a significant deviation is recognized by the supervisor functions that cannot be removed by other means.If a reboot occurs during an active ventilation mode, operation will be restored after a successful completion of the reboot sequence in the same mode with the latest valid settings.As confirmed for the particular case, a reboot will not last longer than 15 seconds when the error condition can be cleared-off.The second aspect of unintended autonomous mode change - reportedly to test mode - can be denied.A mode change requires a two-step input sequence: selecting the new mode via input at the display soft keys and confirming the input command by pressing the rotary knob within a specified period of time; if the second step of confirmation is not recognized within a specified time period, the change sequence will be aborted.This means that the mode change is carried out and supervised by two independent channels.There is no indication that these safety mechanisms failed in this case.The reboot in the particular situation was triggered by a sporadic deviation found with a microprocessor on the board that controls the therapy functions.The device was used for two more days without recurrence of the deviation.The local service organization has however replaced the therapy control board as a precautionary measure.

Event Description

Please refer to initial mfr report #9611500-2019-00365.

• 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: 9271193
• MDR Text Key: 180551306
• Report Number: 9611500-2019-00365
• 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: 04/08/2020

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: 10/07/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1