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); Unexpected Shutdown (4019); Intermittent Communication Failure (4038)

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

Event Date 02/14/2023

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 failed suddenly and the monitor went black.No patient injury was reported.

Event Description

It was reported, that the device failed suddely and the monitor went black.No patient injury was reported.

Manufacturer Narrative

The device log file and the replaced circuit board therapy control unit m16.2 were available for investigation.Based on the log entries the reported event could be confirmed.A reboot was conducted due to a communication disruption between the two microprocessors on the m16.2.After the reset the device returned to the previous valid operating state.During a test run of the replaced circuit board no comparable reboot could be recorded in the logbook nor a hardware fault was detected during a functional test.Although no persistent hardware defect could be determined, the circuit board m16.2 could be identified as root cause for the reported reboot.A reset of the processors on the m16 therapy control unit leads to a interruption of ventilation for a maximum of 15 seconds.Subsequently ventilation will be continued with the last valid settings.If the reset time will be exceeded, an acoustic alarm is generated via the secondary alarm system.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 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 16434597
• MDR Text Key: 310244606
• Report Number: 9611500-2023-00072
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)220218(17)220615(93)MK06000-40
• 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: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• 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
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2022
• 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