MAUDE Adverse Event Report: PHILLIPS MEDICAL SYSTEMS INC PHILLIPS ICT; GANTRY

Model Number 453567449901

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2015

Event Type  Injury  

Event Description

Phillips ict failed mid coronary ct#angio.Gantry acquisition system cannot comply.This has been an ongoing issue with multiple service calls.Exam was nondiagnostic, pt received medication and contrast prior to failure.Exam was completed in another dept, radiology (required patient to be moved).This device was manufactured in nov 2010 or dec 2010.We have had multiple service calls on this device since 09/03/2015 (service 09/03, 09/17; 09/24; 09/29; 10/01; 10/06; 10/14; 10/19; 10/23; 10/26; and 10/30) with service person unable to fix the problem.Manager requested another service person on the date of the event (b)(6) 2015.

• Brand Name: PHILLIPS ICT
• Type of Device: GANTRY
• Manufacturer (Section D): PHILLIPS MEDICAL SYSTEMS INC; cleveland OH 44143
• MDR Report Key: 5210429
• MDR Text Key: 30868067
• Report Number: MW5057737
• Device Sequence Number: 1
• Product Code: JAK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/04/2015

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: Health Professional
• Device Model Number: 453567449901
• Device Catalogue Number: 728306
• Other Device ID Number: 100215
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 78