ADAC NM SYSTEM
Received Aug 12, 2023 · Event occurred Sep 16, 2021
Report MW5141873 · MDR key 17534973
Device
Generic name
Camera, X-ray, Fluorographic, Cine Or Spot
Manufacturer
PhilipsProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Hernia
- Discomfort
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Hernia
- Discomfort
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
THIS IS TO INFORM YOU THAT GE HEALTHCARE RECEIVED A SERVICE REQUEST FROM (B)(6), USA, WHERE A GE SERVICE EMPLOYEE WAS REPORTED TO HAVE A SMALL HERNIA FOLLOWING A SERVICE ACTIVITY ON AN ADAC NM SYSTEM ON (B)(6) 2021. (B)(6) WERE DISASSEMBLING TABLE END COVERS AND PEDESTAL ASSEMBLY. THE FE FELT DISCOMFORT/STRAIN WHILE REMOVING THE PEDESTAL FROM TABLE DRIVE ASSEMBLY. (B)(6) WAS OPERATED AS A MEDICAL TREATMENT FOR THE HERNIA. IT WAS CONFIRMED THAT THERE WAS NO GE HEALTHCARE SYSTEM INVOLVED THAT CAUSED OR CONTRIBUTED TO THE EVENT. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).