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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. GAS-MACHINE, ANESTHESIA

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DRAEGER MEDICAL SYSTEMS, INC. GAS-MACHINE, ANESTHESIA Back to Search Results
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Failure of Device to Self-Test (2937)
Patient Problem No Information (3190)
Event Date 09/27/2016
Event Type  malfunction  
Event Description
Anesthesia cart malfunctioned in sleep mode. It wouldn't run through self-tests and showed error messages. The device was able to complete self tests with re-booting 3 times. Trimedix was notified but couldn't replicate the problem. The problem occurred again 3 days later and the motherboard and light cable were replaced.
 
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Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
DRAEGER MEDICAL SYSTEMS, INC.
3135 quarry rd.
telford PA 18969
MDR Report Key6456227
MDR Text Key71601045
Report Number6456227
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/25/2016,03/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/25/2016
Event Location Hospital
Date Report to Manufacturer10/25/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/04/2017 Patient Sequence Number: 1
Treatment
PATIENT WAS BEING PREPPED FOR SURGERY, DRAGER ANES
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