MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. GE POWER CORD; DETECTOR AND ALARM, ARRHYTHMIA

Device Problems Fire (1245); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2020

Event Type  malfunction  

Event Description

A power cord plug on a ge dash 4000 physiological monitor caught on fire at the outlet's end.The power cord and electrical outlet were replaced.The room was empty at the time of the fire and there was no harm to patients or staff.It is suspected that the plug of the power cord was fatigued and/or worn out from plugging and unplugging the unit.Service and preventative maintenance history were analyzed and we found no discrepancies.An electrical safety test to the main monitor successfully passed following manufacturer recommendations.Staff personnel were re-educated on the need to visually inspect power cords and on the process to report any damage.Gems-it 80274 rev:b mfr.09/13.Fda safety report id #(b)(4).

• Brand Name: GE POWER CORD
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• MDR Report Key: 10414434
• MDR Text Key: 203152805
• Report Number: MW5096090
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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