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U.S. Department of Health and Human Services

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

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DRÄGERWERK AG & CO. KGAA PERSEUS A500; ANESHESIA UNITS Back to Search Results
Catalog Number MK06000
Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Reset Problem (3019); Intermittent Communication Failure (4038)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/23/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation was just started.The results will be forwarded in a follow up report.
 
Event Description
It was reported that while a patient was connected to the machine, the screen from a500 turned white for 30 seconds and got back to normal after.No injury reported.
 
Event Description
It was reported that while a patient was connected to the machine, the screen from a500 turned white for 30 seconds and got back to normal after.No injury reported.
 
Manufacturer Narrative
The electronic device log file was provided for investigation.The reported observation can be generally confirmed: the device had performed a system reboot during the procedure in question and resumed ventilation after 13 seconds.Since the special signature of the logged error codes point to a malfunction of the subsystem "therapy control unit, a replacement of the particular pcb was recommended as a precautionary measure despite the error condition was of temporary nature only.A reboot of the processors onboard the therapy control unit would incorporate a short-term outage of therapy functions for a maximum of 15 seconds.This will be brought to the operator's attention by corresponding alarms.After resuming processor operation, the therapy will be continued with the previous settings.No patient consequences have been reported for the particular therapy episode.Currently there is no indication for a trend in reboot failures for this type of board in the field.The evaluation of the previously reported instances has not produced any clear finding in regard to the condition that triggered the processor reboot.Dräger finally concludes that the workstation has responded to the malfunction of a single component/subsystem as designed: a reboot was performed to overcome the error condition and the appropriate alarm was posted.
 
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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 Key11331708
MDR Text Key246315357
Report Number9611500-2021-00068
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675253600
UDI-Public(01)04048675253600(11)191115(17)200625(93)MK06000-38
Combination Product (y/n)N
PMA/PMN Number
K133886
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 03/23/2021
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 NumberMK06000
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/27/2021
Initial Date FDA Received02/16/2021
Supplement Dates Manufacturer Received03/15/2021
Supplement Dates FDA Received03/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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