MAUDE Adverse Event Report: GE NUCLEAR MEDICINE CAMERA; SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

Model Number MELLENIUM MG

Device Problem Mechanical Problem (1384)

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

Event Date 11/14/2019

Event Type  malfunction  

Event Description

Camera table would not raise / lower during a nuclear stress test.Pt could not have test complete.Fda safety report id# (b)(4).

• Brand Name: NUCLEAR MEDICINE CAMERA
• Type of Device: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): GE; norwich NY 13815
• MDR Report Key: 9383966
• MDR Text Key: 168454394
• Report Number: MW5091331
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MELLENIUM MG
• Was Device Available for Evaluation?: No
• 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
• Patient Age: 85 YR