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U.S. Department of Health and Human Services

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

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DRAEGERWERK AG & CO. KGAA PERSEUS A500 GAS-MACHINE, ANESTHESIA Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Respiratory Distress (2045)
Event Date 01/16/2019
Event Type  malfunction  
Event Description
Doctor attempted to swap out the absorbent canister during a case. After the swap, the patient's inspired co2 levels increased. Dr was not able to resolve the problem. Ended up having to bag patient using an ambu-bag and transport patient to another operating room down the hall. Manufacturer response for anesthesia ventilator, (brand not provided) (per site reporter). They came out, tested the ventilator and stated the problem was that the absorber was installed incorrectly. The ventilator passed all "tested" and was deemed ready to be returned to service.
 
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Brand NamePERSEUS A500
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
DRAEGERWERK AG & CO. KGAA
3135 quarry rd.
telford PA 18969
MDR Report Key8276856
MDR Text Key134067249
Report Number8276856
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 Biomedical Engineer
Type of Report Initial
Report Date 01/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2019
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/22/2019
Device Age5 MO
Event Location Hospital
Date Report to Manufacturer01/25/2019
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? No
Type of Device Usage

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