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U.S. Department of Health and Human Services

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

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DRÄGERWERK AG & CO. KGAA PERSEUS A500 ANESTHESIA UNITS Back to Search Results
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.
 
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Brand NamePERSEUS A500
Type of DeviceANESTHESIA 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 Key11377677
MDR Text Key233455895
Report Number9611500-2021-00088
Device Sequence Number1
Product Code BSZ
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
Report Date 02/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMK06000
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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