MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PERSEUS A500; ANESHESIA UNITS

Catalog Number MK06000

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2020

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 performed a restart during use.There was no patient injury reported.

Event Description

Please refer to initial mfr.Report #9611500-2020-00179.

Manufacturer Narrative

The device was subject to an on-site evaluation.It did not exhibit any deviations during the tests; the error condition could not be reproduced.Log file evaluation carried out by the manufacturer revealed that two instances of a communication interrupt between the two processors onboard the therapy control unit have occurred within a minute.The device is designed to trigger a system reboot when such condition occurs.The reboot resulted in a short-term outage of therapy functions for not more than 15 seconds and was accompanied by a corresponding alarm before the therapy was resumed with the last valid settings.The particular procedure was continued and went stable and unremarkable until it was finished approximately four hours later.Although the source of the deviation can be attributed to the particular pcb the exact nature of the issue can't be determined due to its sporadic nature.The number of similar cases, related to the same phenomeon, is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: PERSEUS A500
• Type of Device: ANESHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10094929
• MDR Text Key: 194322927
• Report Number: 9611500-2020-00179
• 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,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• 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: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1