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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 Loss of Power (1475); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2019
Event Type  malfunction  
Manufacturer Narrative
The investigation has just started; results will be provided in our follow-up report.
 
Event Description
It was reported that the device switched off during use and it was not possible to turn it on again. It was further reported that the device went out but the alarm ¿no fresh gas delivery¿ was displayed. There was no patient injury reported.
 
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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 Contact
sonja hillmer
moislinger allee 53-55
lübeck 23542
GM   23542
4518822868
MDR Report Key8779465
MDR Text Key150700502
Report Number9611500-2019-00203
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K133886
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2000
Device Catalogue NumberMK06000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/30/2012
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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