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U.S. Department of Health and Human Services

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

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DRÄGERWERK AG & CO. KGAA PERSEUS GAS-MACHINE, ANESTHESIA Back to Search Results
Device Problems Unable to Obtain Readings (1516); Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/04/2019
Event Type  malfunction  
Event Description
After induction the anesthesia machine had a gas sensor fail. The etco2, o2 and desflurane were no longer reading any measurements. The anesthetic had to be converted to a iv anesthetic and a portable ventilator was utilized along with a bis monitor. The pt was stable throughout.
 
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Brand NamePERSEUS
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
3135 quarry rd.
telford PA 18969
MDR Report Key9139918
MDR Text Key160722834
Report Number9139918
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 Risk Manager
Type of Report Initial
Report Date 09/09/2019,09/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2019
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/09/2019
Event Location Hospital
Date Report to Manufacturer10/01/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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