MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. DRAEGER INFINITY M3000 CHARGER; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number MS25699

Device Problems Fire (1245); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2021

Event Type  malfunction  

Event Description

Draeger remote telemetry monitor was in docking station when docking station combust into flames and telemetry box flew across the room off of the docking station.Fda safety report id # (b)(4).

• Brand Name: DRAEGER INFINITY M3000 CHARGER
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC.
• MDR Report Key: 12698076
• MDR Text Key: 278382963
• Report Number: MW5104952
• Device Sequence Number: 1
• Product Code: MHX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MS25699
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other