MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC REVOLUTION CT; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number CSRV01

Device Problem Sharp Edges (4013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Unique identifier: udi not required.Legal manufacturer: (b)(4).Ge healthcare (gehc) reported a field modification for this issue per 21 cfr 806 gehc ref# (b)(4).

Event Description

Received information that the table pinch protector may have come off leaving standing flat-head screws.There was no injury involved with this malfunction event.

• Brand Name: REVOLUTION CT
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 11701296
• MDR Text Key: 250614044
• Report Number: 2126677-2021-00041
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K133705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSRV01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: GEHC REF# 25496
• Patient Sequence Number: 1