MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS, INC OEC ELITE; FLUOROSCOPIC XRAY

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Crushing Injury (1797)

Event Date 04/04/2023

Event Type  malfunction  

Manufacturer Narrative

Ge healthcareâs investigation is ongoing.This mdr is being filed in an abundancy of caution at this time.Block d4 unique identifier: (b)(4).Legal manufacturer: surgery slc - 384 n wright brothers dr usa salt lake city, ut 84116.

Event Description

On april 4, 2023, it was discovered internally that the system had a separated image intensifier.There was no injury related to this event.

Manufacturer Narrative

Ge healthcare's (gehc) investigation has been completed and the cause was determined to be a gehc specification not being met by a supplier of the image intensifier.As a result of the investigation a correction was initiated by gehc (recall no.Fmi 15146) and filed to fda.The device had not yet been installed or placed in use as the issue occurred during transit and therefore there was no patient or user involvement.

• Brand Name: OEC ELITE
• Type of Device: FLUOROSCOPIC XRAY
• Manufacturer (Section D): GE OEC MEDICAL SYSTEMS, INC; 384 n wright brothers dr; salt lake city, UT 84116
• Manufacturer (Section G): GE OEC MEDICAL SYSTEMS, INC; 384 n wright brothers dr; salt lake city, UT 84116
• Manufacturer Contact: troy perry ; 384 wright brothers drive; salt lake city, UT 84116
• MDR Report Key: 16880116
• MDR Text Key: 314673912
• Report Number: 1720753-2023-00002
• Device Sequence Number: 1
• Product Code: OBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Lot Number: FSXXTX00421
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1