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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CX50; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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CX50; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number CX50 DIAGNOSTIC ULTRASOUND SYSTEM
Device Problem Failure to Power Up (1476)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/21/2021
Event Type  malfunction  
Manufacturer Narrative
An investigation is underway to determine the root cause of the issue.Results of the investigation will be included in a follow up report upon its completion.
 
Event Description
A customer reported their cx50 ultrasound system would not power up to perform transesophageal echocardiography (tee) imaging at the end of a cardiac procedure.The procedure was able to be completed successfully with no harm or impact to the patient¿s outcome.
 
Manufacturer Narrative
A philips field service engineer performed a thorough inspection of the cx50 ultrasound system and determined the reported issue was caused by a failed ac adapter and battery.The service engineer repaired the system by replacing the ac adapter and battery.The suspect parts were inadvertently discarded prior to returning for evaluation, therefore, no additional failure analysis could be performed.The system has returned to service with no similar issues reported.
 
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Brand Name
CX50
Type of Device
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
MDR Report Key11257800
MDR Text Key229581485
Report Number3019216-2021-00018
Device Sequence Number1
Product Code IYN
UDI-Device Identifier00884838097964
UDI-Public00884838097964
Combination Product (y/n)N
PMA/PMN Number
K123754
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCX50 DIAGNOSTIC ULTRASOUND SYSTEM
Device Catalogue Number795087
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date02/10/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/08/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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