MAUDE Adverse Event Report: GE HEALTHCARE LIGHTSPEED PRO 16; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problem Protective Measures Problem (3015)

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

Event Date 08/19/2019

Event Type  malfunction  

Event Description

During drain placement the ge scanner produced an error message "scanning hardware fail".System rebooted and new error message "scanner hardware stopped".Needle for placement was removed from patient.The patient moved to a different scanner and procedure completed.

• Brand Name: LIGHTSPEED PRO 16
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): GE HEALTHCARE; 3000 n grandview blvd.; waukesha WI 53188
• MDR Report Key: 9005642
• MDR Text Key: 157731397
• Report Number: 9005642
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/29/2019,08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18980 DA
• Patient Weight: 80