FDA Adverse Event
Malfunction
Summary report: N
INTEGRIS H3000
MDR report key: 1912519
·
Received November 17, 2010
Report
- Report Number
- 3003768277-2010-00310
- Event Type
- Malfunction
- Date Received
- November 17, 2010
- Date of Event
- October 21, 2010
- Report Date
- October 21, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- IZF
- PMA / PMN Number
- K925302
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(CONCLUSIONS) - METHOD AND RESULTS (OTHER) - THIS SYSTEM PROBLEM WAS SOLVED BY REPLACING SEVERAL HARDWARE COMPONENTS. THE EXACT ROOT CAUSE IS UNK. THE SYSTEM WAS REPAIRED BY THE REPLACEMENT OF SEVERAL HARDWARE COMPONENTS WHICH MIGHT HAVE CONTRIBUTED TO THE REPORTED PROBLEM. NONE OF THESE COMPONENTS HAVE EXCEPTIONAL OR INCREASED FAILURE RATES. THE FAILURE RATES ARE MONITORED FOR THESE COMPONENTS. THEREFORE, RISK TO PT REMAINS ACCEPTABLE. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THIS X-RAY SYSTEM STOPPED DURING AN EXAMINATION WITH A PT ON THE TABLE. THE SYSTEM WOULD NOT RESTART.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRIS H3000 | IZF (SYSTEM, XRAY, TOMOGRAPHIC) | IZF | PHILIPS MEDICAL SYSTEMS | 72238 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |