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

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.

• 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 Key: 7482665
• MDR Text Key: 107218773
• Report Number: 7482665
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Number: V500
• Other Device ID Number: VENTILATOR BATTERY
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2018
• 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 Number: 1