MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS X5-1; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number X5-1

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Overheating of Device (1437)

Patient Problem No Information (3190)

Event Date 02/27/2015

Event Type  malfunction  

Event Description

Echo probe overheated and echo machine froze during echo study on a patient.It also has frozen when the machine was not actively being used on a patient.This was a recurring problem at the site.It occurred on 2 probes, on multiple patient uses.One of the probes exhibited the overheating issue right out of the box.Both of these 2 probes have been returned to the field service rep.The manufacturer is aware of this problem happening at other hospitals.It is possible that the overheating is due to the crystals in the probe spinning continually, which is not supposed to happen.

• Brand Name: X5-1
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 4696650
• MDR Text Key: 5643142
• Report Number: 4696650
• Device Sequence Number: 1
• Product Code: ITX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/27/2015

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: Other
• Device Model Number: X5-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1