FDA Adverse Event
Malfunction
Summary report: N
ZFP
MDR report key: 5101331
·
Received September 24, 2015
Report
- Report Number
- 3004526608-2015-00003
- Event Type
- Malfunction
- Date Received
- September 24, 2015
- Report Date
- August 25, 2015
- Manufacturer
- GE HEALTHCARE IT
- Product Code
- LLZ
- PMA / PMN Number
- K131977
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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.
Additional Manufacturer Narrative · 1
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
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632781 | ZFP | SYSTEM, IMAGE PROCESSING, RADIOLOGIC | LLZ | GE HEALTHCARE IT | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |