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); Intermittent Communication Failure (4038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the log file revealed that the device passed the automatic system test in the morning of the date of event without deviations.In the beginning of the concerned procedure the ventilation was disturbed by leakages in the pneumatic circuit which were indicated to the user by means of corresponding alarms.After approximately one hour the system triggered a reboot of one of the microprocessors onboard the so-called therapy control unit, the subsystem which controls ventilation and gas dosage.The reboot was successfully completed after a few seconds; therapy was resumed afterwards with the last valid settings as intended.The procedure was continued for 7.5 hours without further issues.The triggering condition for the processor reboot could not be determined by log file analysis.There's no causal connection to the initial leakages.The fact that this was a sporadic occurrence only would suggest that an external disturbance may have caused the reboot e.G.An electromagnetic impulse that exceeded the immunity barriers and led to communication interrupt between the internal subsystems.A reliable conclusion however can't be drawn since the event left no footprints and the device exhibited no deviations during testing in follow-up of the event.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 performed a reboot during a running ventilation episode.After successful completion of the boot sequence the device continued ventilation with previous settings; no patient consequences have reportedly occurred.

• Brand Name: PERSEUS A500
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11377677
• MDR Text Key: 233455895
• Report Number: 9611500-2021-00088
• 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
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• 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
• Date Manufacturer Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2017
• 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