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

Model Number CSRV02

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
• Manufacturer Contact: susan strasser ; 3000 n grandview blvd; waukesha, WI
• MDR Report Key: 11586181
• MDR Text Key: 250614192
• Report Number: 2126677-2021-00038
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSRV02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2016
• 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