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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 Failure to Deliver (2338); Computer System Security Problem (2899); Inappropriate or Unexpected Reset (2959)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/21/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Event Description
It was reported that the ventilator failed during use. 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
GM
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
MDR Report Key12479063
MDR Text Key272692040
Report Number9611500-2021-00391
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675253600
UDI-Public(01)04048675253600(11)170425(17)180203(93)MK06000-33
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2021
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 Received10/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2017
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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