FDA Adverse Event
Malfunction
Summary report: N
INFINIA HAWKEYE4
MDR report key: 1071711
·
Received July 9, 2008
Report
- Report Number
- 9613299-2008-00004
- Event Type
- Malfunction
- Date Received
- July 9, 2008
- Date of Event
- June 10, 2008
- Report Date
- June 10, 2008
- Manufacturer
- GEMS ISRAEL, FUNCTIONAL IMAGING
- Product Code
- KPS
- PMA / PMN Number
- K991841
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
GE'S INVESTIGATION OF THE MISREGISTRATION CONCLUDED THAT THE ISSUE RESULTS FROM THE HEADREST ACCESSORY USED DURING HYBRID SPECT SCANS AND IS NOT SUPPORTED BY THE PALLET SUPPORT MECHANISM. THEREFORE, SAGGING OCCURS WHEN A PATIENT'S HEAD RESTS ON THE ACCESSORY. THIS SAGGING CAUSES A MISMATCH BETWEEN THE TWO FUSED IMAGES. A FIELD CORRECTION IS PLANNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT 10MM MISREGISTRATION WAS OBSERVED IN A HYBRID SPECT SCAN PERFORMED USING A PHANTOM LAID ON THE HEADREST. THERE WAS NEITHER PT INVOLVEMENT NOR INJURY REPORTED. THE CONCERN IS FOR A POTENTIAL MISDIAGNOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINIA HAWKEYE4 | KPS | GEMS ISRAEL, FUNCTIONAL IMAGING | H3000WC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |