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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PERSEUS A500; GAS-MACHINE, ANESTHESIA

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DRÄGERWERK AG & CO. KGAA PERSEUS A500; GAS-MACHINE, ANESTHESIA Back to Search Results
Model Number MK06000
Device Problems Mechanical Problem (1384); Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2022
Event Type  malfunction  
Event Description
Anesthesia machine had a failure in operating room.As an anesthesia tech, we took all necessary measures to see why the machine kept failing.We notified biomed- dayshift about the issue/ and concerns and they confirmed and relayed to the next shift about the issue.Biomed was able to fix air leak in machine.Machine returned to service.There was no harm or patient involved.
 
Event Description
Anesthesia machine had a failure in or.As an anesthesia tech, we took all necessary measures to see why the machine kept failing.We notified biomed- dayshift about the issue/ and concerns and they confirmed and relayed to the next shift about the issue.Biomed was able to fix air leak in machine.Machine returned to service.There was no harm or patient involved.
 
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Brand Name
PERSEUS A500
Type of Device
GAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
6 tech drive
andover MA 01810
MDR Report Key15146138
MDR Text Key297065264
Report Number15146138
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMK06000
Device Catalogue NumberMK06000
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/20/2022
Event Location Hospital
Date Report to Manufacturer08/02/2022
Type of Device Usage Unknown
Patient Sequence Number1
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