MAUDE Adverse Event Report: GE HEALTHCARE (VIEWPOINT BILDVERARBEITUNG GMBH) VIEWPOINT 5; RADIOLOGICAL IMAGE PROCESSING SYSTEM

Model Number 5.6.12

Device Problems False Positive Result (1227); Use of Device Problem (1670); Human-Device Interface Problem (2949)

Patient Problem Miscarriage (1962)

Event Date 04/11/2014

Event Type  Death  

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow up report will be provided after the investigation has been completed.

Event Description

The hospital reported a "spontaneous" abortion of a fetus had occurred as a result of an invasive procedure (amniocentesis) which was recommended by the physician based on an incorrect trisomy risk calculation value produced by the viewpoint system.The user admits to not following the instructions for use, which required the date of the blood sample analysis (which is used within the risk calculation) to be updated prior to using the calculated risk value.There was no allegation of device malfunction.

• Brand Name: VIEWPOINT 5
• Type of Device: RADIOLOGICAL IMAGE PROCESSING SYSTEM
• Manufacturer (Section D): GE HEALTHCARE (VIEWPOINT BILDVERARBEITUNG GMBH); wessling ; GM
• Manufacturer (Section G): GE HEALTHCARE (VIEWPOINT BILDVERARBEITUNG GMBH); wessling ; GM
• Manufacturer Contact: james giles ; 3000 n. grandview blvd.; waukesha, WI 53188 ; 2625482089
• MDR Report Key: 4116928
• MDR Text Key: 19533057
• Report Number: 3004497354-2014-00001
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K103458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5.6.12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2011
• 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
• Patient Outcome(s): Death
• Patient Age: 37 YR