MAUDE Adverse Event Report: GE HEALTHCARE IT ZFP; SYSTEM, IMAGE PROCESSING, RADIOLOGIC

Device Problems Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Internally found issue.There was no patient involvement.Internally found issue.No incident date.Ge healthcare's investigation is ongoing.A follow-up report will be submitted when the investigation is complete.Device evaluation anticipated, but not yet begun.

Event Description

Internally found issue.Distance measurements may not be calculated accurately by zero footprint versions 5.0 sp2 to sp7 when applied to images acquired with a magnification factor.

Manufacturer Narrative

The investigation determined the root cause was no documented zfpv requirements for specific dicom tags that developers can follow during design and implementation.Issue was resolved through normal development cycle in revision 6.0 of zfpv.

• Brand Name: ZFP
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGIC
• Manufacturer (Section D): GE HEALTHCARE IT; 540 w. northwest hwy; barrington IL 60010
• Manufacturer (Section G): GE HEALTHCARE; 540 w. northwest hwy.; barrington IL 60010
• Manufacturer Contact: deb lahr ; 540 w. northwest hwy.; barrington, IL 60010
• MDR Report Key: 5101331
• MDR Text Key: 26837577
• Report Number: 3004526608-2015-00003
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K131977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1