FDA Adverse Event
Malfunction
Summary report: N
INTEGRIS HM3000
MDR report key: 1942703
·
Received November 29, 2010
Report
- Report Number
- 3003768277-2010-00340
- Event Type
- Malfunction
- Date Received
- November 29, 2010
- Date of Event
- November 5, 2010
- Report Date
- November 5, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- IZF
- PMA / PMN Number
- K925302
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(CONCLUSIONS) - THE INVESTIGATION FOUND THE REPLACEMENT OF COMPONENT, FIGARO II GENERATOR CONTROL, CORRECTED THE PROBLEM. BASED ON TRENDING ANALYSIS THERE IS NO EXCEPTIONAL REPLACEMENT RATE OF THIS PART. THERE IS NO REQUIRED MANDATORY FIELD ACTION.
Description of Event or Problem · 1
THIS X-RAY SYSTEM WENT DOWN WITH PT ON TABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRIS HM3000 | IZF (SYSTEM, X-RAY, TOMOGRAPHIC) | IZF | PHILIPS MEDICAL SYSTEMS | 72239 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |