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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
Model Number MK06000
Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Failure to Deliver (2338); Intermittent Communication Failure (4038)
Patient Problem Insufficient Information (4580)
Event Date 01/11/2022
Event Type  malfunction  
Event Description
It was reported that the perseus shut down while the patient was connected to the device. There was no patient injury reported.
 
Manufacturer Narrative
The investigation is still on-going. The results will be provided with a follow-up report.
 
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Brand NamePERSEUS A500
Type of DeviceANESTHESIA 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 Key13421449
MDR Text Key287250388
Report Number9611500-2022-00027
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675253600
UDI-Public(01)04048675253600(11)151027(17)160426(93)MK06000-30
Combination Product (y/n)N
PMA/PMN Number
K133886
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMK06000
Device Catalogue NumberMK06000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2015
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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