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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. DRAEGER V500 (EVITA INFINITY); CONTINUOUS VENTILATOR

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DRAEGER MEDICAL SYSTEMS, INC. DRAEGER V500 (EVITA INFINITY); CONTINUOUS VENTILATOR Back to Search Results
Model Number V500
Device Problems Premature Discharge of Battery (1057); Computer Software Problem (1112); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported that per the manufacturer's instructions for use for draeger v500 ventilators, a battery check is required every 90 days.After approximately a year of use, the battery check has provided an error alert on four devices that the batteries are recommended to be changed.Due to the error alert, the devices have been pulled from service.Per the manufacturer, batteries are to last 2 years before recommended replacement.Draeger representatives have indicated that this battery check is causing issues with early battery replacement and a software update is being worked on to resolve the issue.The vendor has indicated that a software update may be available in the future.The batteries are on backorder with no date for when replacements will be provided.To date, there has been no patient harm.
 
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Brand Name
DRAEGER V500 (EVITA INFINITY)
Type of Device
CONTINUOUS VENTILATOR
Manufacturer (Section D)
DRAEGER MEDICAL SYSTEMS, INC.
6 tech dr.
andover MA 01810
MDR Report Key7482665
MDR Text Key107218773
Report Number7482665
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberV500
Other Device ID NumberVENTILATOR BATTERY
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/01/2018
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer05/01/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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