FDA Adverse Event
Malfunction
Summary report: N
AMX 4
MDR report key: 1001251
·
Received February 22, 2008
Report
- Report Number
- 2126677-2008-00013
- Event Type
- Malfunction
- Date Received
- February 22, 2008
- Date of Event
- January 23, 2008
- Report Date
- January 23, 2008
- Manufacturer
- GE MEDICAL SYSTEMS, LLC
- Product Code
- IZL
- PMA / PMN Number
- K802047
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND THAT ONE SCREW WAS HOLDING THE COLLIMATOR WHILE THE REST OF THE SCREWS WERE MISSING. THE FE INSTALLED NEW SCREWS AND RETURNED THE PRODUCT BACK TO SERVICE. PROPER PREVENTIVE MAINTENANCE IS CURRENTLY IN PLACE PER THE GE PREVENTATIVE MAINTENANCE TO DETECT THIS TYPE OF ISSUE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE COLLIMATOR WAS LOOSE. THERE WAS NEITHER INJURY REPORTED NOR PATIENT INVOLVEMENT. THE CONCERN WAS FOR A SERIOUS INJURY IF THE COLLIMATOR WERE TO FALL ON A PATIENT OR AN OPERATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMX 4 | IZL | GE MEDICAL SYSTEMS, LLC | 46-270615P1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |