FDA Adverse Event
Injury
Summary report: N
BRIGTHVIEW XCT
MDR report key: 1830917
·
Received September 7, 2010
Report
- Report Number
- 2916556-2010-00017
- Event Type
- Injury
- Date Received
- September 7, 2010
- Date of Event
- August 18, 2010
- Report Date
- August 18, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS, INC
- Product Code
- KPS
- PMA / PMN Number
- K080927
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE ROOT CAUSE OF THIS ISSUE HAS BEEN IDENTIFIED AS OPERATOR ERROR IN POSITIONING THE PATIENT. THE BRIGHTVIEW XCT INSTRUCTIONS FOR USE HAS INSTRUCTIONS FOR THE OPERATOR TO RESTRAIN THE PATIENT'S HANDS SO, THEY DO NOT GET CAUGHT BETWEEN THE TABLE PALLET AND THE CATCHER. (B)(4).
Description of Event or Problem · 1
DURING A MYOCARDIAL SCINTIGRAPHY, A PATIENT'S HAND INADVERTENTLY SLIPPED BETWEEN THE TABLE AND THE CATCHER CAUSING INJURY TO THE HAND. THERE WAS NO REPORT OF ANY BROKEN BONES. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM WHERE IT WAS DETERMINED THAT THE INCURRED INJURY WILL REQUIRE STITCHES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRIGTHVIEW XCT | SPECT/CT SYSTEM | KPS | PHILIPS MEDICAL SYSTEMS, INC | 453560749161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |