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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. INFINITY; SYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS
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DRAEGER MEDICAL SYSTEMS, INC. INFINITY; SYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS Back to Search Results
Model Number C500
Device Problems Computer Software Problem (1112); Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/18/2014
Event Type  malfunction  
Event Description
Front door panel latch was broken and the part was replaced.While turning vent on to run a device check, a hard drive failure occurred.This seems to be a common issue with these vents.Ordered a replacement hard drive, as tech support recommended, then reloaded software.This did not fix problem.The next recommendation from tech support was to load a newer software version from 2.31 to 2.41.No success with this either.Now vent is awaiting a field service tech to perform the latest device correction consisting of upgrading hard drive and batteries.
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manufacturer response for ventilator, c500/vn500 babylog (per site reporter).
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field service tech is coming in to fix vent.
 
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Brand Name
INFINITY
Type of Device
SYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS
Manufacturer (Section D)
DRAEGER MEDICAL SYSTEMS, INC.
6 tech drive
andover, MA 01810
MDR Report Key4493985
MDR Text Key20776397
Report Number4493985
Device Sequence Number2
Product Code MHX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 12/11/2014
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Invalid Data
Device Model NumberC500
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/11/2014
Device Age4 YR
Event Location Hospital
Date Report to Manufacturer02/09/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/11/2014
Patient Sequence Number1
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