MAUDE Adverse Event Report: GE HEALTHCARE GMBH VIEWPOINT 6; RADIOLOGICAL IMAGE PROCESSING SYSTEM

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that the scan image that was displayed on viewpoint 6 did not correspond to the dicom info for the patient.No report of serious injury.

Manufacturer Narrative

Ge healthcare's investigation of the reported event is ongoing.A follow up report will be submitted once the investigation has been completed.Block a: patient data was not provided by the hospital.Event date: the incident date is unk.The occupation of the initial reporter is unk.Device manufacture date unk.

• Brand Name: VIEWPOINT 6
• Type of Device: RADIOLOGICAL IMAGE PROCESSING SYSTEM
• Manufacturer (Section D): GE HEALTHCARE GMBH; munich ; GM
• Manufacturer (Section G): GE HEALTHCARE GHBH; munich ; GM
• Manufacturer Contact: james giles ; 3000 n. grandview blvd; w450; waukesha, WI 53188 ; 2625482089
• MDR Report Key: 4260875
• MDR Text Key: 4987063
• Report Number: 3004497354-2014-00002
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1