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

Catalog Number MK06000

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Intermittent Communication Failure (4038)

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

Event Date 03/11/2024

Event Type  malfunction  

Event Description

It was reported that the device performed a reboot during a surgical procedure.Since function was restored, the user decided to finish the surgery with the device.No patient consequences were reportedly resulting from the event.

Manufacturer Narrative

The device was checked by a dräger service engineer who performed an initial review of the log file and replaced the circuit board that controls the therapy functions as well as a memory (cf) card.The device passed all consecutive test and could be returned to use.A detailed log file analysis was provided by the manufacturer; the reported issue could be reconstructed.The ventilation of the concerned procedure went stable and uneventful in the beginning until the therapy control unit performed a reboot to overcome a deviation in the sw processing.The reboot was successfully completed after 12 seconds and, the device resumed ventilation with previous settings.The user shortly switched to standby and was then using an automatic ventilation mode to complete the surgery without additional issues.The root cause for the deviation in the sw processing could not be determined.The log did not contain further instances of this failure.Dräger finally concludes that the device responded as designed upon a deviation of unknown origin; a reboot was initiated to set all sw processes back to a controlled state, the user was alerted to the reboot by means of a corresponding alarm and, therapy was continued afterwards with the latest valid settings.The parts that could be put in causal connection to the event have been replaced as a precautionary measure.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
• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 19077717
• MDR Text Key: 340681309
• Report Number: 9611500-2024-00155
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)180705(17)190214(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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/10/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2018
• 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