MAUDE Adverse Event Report: PHILIPS SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 08/10/2015

Event Type  Injury  

Event Description

This is to inform you that ge healthcare received a service request from (b)(6) hospital, (b)(6), where a ge service employee was reported to have sustained a wrist and shoulder injury while de-installing a philips ct system on (b)(6) 2015.The employee had surgery on (b)(6) 2015 and the event was recorded as u.S.Osha recordable on that same day.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).

• Brand Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS
• MDR Report Key: 17534273
• MDR Text Key: 321158794
• Report Number: MW5141176
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1