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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2022

Event Type  malfunction  

Event Description

It was reported that the device did a reboot.There was no patient injury reported.

Manufacturer Narrative

For the investigation the logfile was analyzed.On the reported date of event the case in question was started using man/spont.After changing to volume control af ventilation was unremarkable and stable.After about one hour of operation a communication interrupt between both processors of the therapy control unit m16.2 was detected, in consequence leading to a processor reset.Therapy was discontinued for a maximum of 15 seconds before therapy resumed with the latest valid settings.The exact root cause for the communication interrupt between the processors of the therapy control unit m16.2 couldn¿t be determined as the requested hardware was not made available for investigation.Dräger finally concludes that the workstation has responded to the malfunction of a single component as designed - a reboot was performed to overcome the error condition and the appropriate alarm was posted.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
• MDR Report Key: 15282297
• MDR Text Key: 302969946
• Report Number: 9611500-2022-00214
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)191120(17)200628(93)MK06000-38
• 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
• Report Date: 08/24/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2019
• 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