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

Model Number MK06000

Device Problems Failure to Deliver (2338); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2022

Event Type  malfunction  

Event Description

It was reported that the device shut down and restarted during use.No injury reported.

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Manufacturer Narrative

The case in question was reconstructed based on the log analysis.The reported reboot could be confirmed and was caused by a memory overload of a processor on the main processor board.In case of a reset of the processors on the main processor board the therapy is discontinued for maximum 15 seconds.Afterwards, the therapy will resume with the previous valid ventilation mode and settings as is could be confirmed for the current case.The root cause for the high memory allocation could not be identified.No hints were found pointing to a potential hardware failure.As an usb stick was permanently installed it was requested for investigation.The analysis of the usb stick has not revealed any abnormalities.The usb stick was connected to a laboratory device.During operation in different system states and modes no reboot or any log sequences comparable to the complained device arose either.After the device had been in operation for further 6 months, another log evaluation was carried out with regard to reoccurrence of any reboots.The log contained neither reboots nor any indication for an increased memory allocation.Besides this, it was found that the device was kept in standby/ operation for months without switching the device off.Such extended periods bear a risk, as some safety systems can only be checked during the start of the device.The ifu provides a respective warning in chapter "turning on perseus" and recommends at least a monthly restart.Finally, the exact root cause could not be determined.It can be concluded that the device reacted as specified on a detected memory allocation and has triggered a reboot which solved the issue.

Event Description

It was reported that the device shut down and restarted during use.No injury reported.

• Brand Name: PERSEUS A500
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 14101320
• MDR Text Key: 297359842
• Report Number: 9611500-2022-00100
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)181019(17)190528(93)MK06000-35
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MK06000
• Device Catalogue Number: MK06000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1