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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 Failure to Deliver (2338); Computer System Security Problem (2899); Inappropriate or Unexpected Reset (2959); No Pressure (2994)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/19/2019
Event Type  malfunction  
Manufacturer Narrative
The investigation is still on-going. The results will be provided within a follow-up report.
 
Event Description
In was reported that during use on patient the screen turned white for a few seconds. Afterwards the curves reappeared and the touch function worked again. No 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 (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
MDR Report Key9294572
MDR Text Key180411187
Report Number9611500-2019-00375
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675253600
UDI-Public(01)04048675253600(11)180807(17)190318(93)MK06000-35
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 06/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2019
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2018
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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