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

Model Number MK06000

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Failure to Deliver (2338); Intermittent Communication Failure (4038)

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

Event Date 08/29/2022

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 alarmed during a running surgical procedure and performed a reboot.Therapy was reportedly resumed after successful completion of the reboot sequence but the operators decided to replace the device in abundance of caution.No patient consequences have reportedly occurred.

Manufacturer Narrative

The user was seeking dräger's assistance and provided a log file to the technical support team.Upon initial log file review it was recommended to replace the pcb which controls the therapy functions and a memory card.The device was tested afterwards and returned to use.A detailed log file review performed by the manufacturer confirmed the validity of the initial expertise - the triggering condition for the observed reboot was a communication interrupt between the two processors onboard the therapy control pcb.The reboot is the specified response to overcome this error condition; a corresponding alarm is being posted to alert the user.The log provides evidence that the remedy was successful; the device resumed therapy with previous settings after some seconds.The replaced parts were subject to a functional test but no hardware defects could be identified.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that the device alarmed during a running surgical procedure and performed a reboot.Therapy was reportedly resumed after successful completion of the reboot sequence but the operators decided to replace the device in abundance of caution.No patient consequences have reportedly occurred.

• 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
• MDR Report Key: 15504944
• MDR Text Key: 300806508
• Report Number: 9611500-2022-00245
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)210609(17)220118(93)MK06000-39
• 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,Followup
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• 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: MK6000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• 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