FDA Adverse Event
Malfunction
Summary report: N
INTERA 1.5T POWER/PULSAR
MDR report key: 3023248
·
Received February 27, 2013
Report
- Report Number
- 3003768277-2013-00008
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Report Date
- January 29, 2013
- Manufacturer
- PHILIPS HEALTHCARE - BEST NETHERLANDS
- Product Code
- LNH
- PMA / PMN Number
- K001796
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): (METHOD, RESULTS, CONCLUSIONS) - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
THE HEART SENSOR (VECTOR CARDIOGRAM, VCG) IS AN OPTIONAL DEVICE FOR PHILIPS MR SYSTEMS AND IS USED FOR TRIGGERING PURPOSES ONLY, TO CREATE AN IMAGE THAT IS NOT DISTURBED BY HEART MOTION. THIS VCG SENSOR IS A WIRELESS DEVICE AND POWERED BY A BATTERY. THE CUSTOMER REPORTED THAT THE VCG BATTERY WAS PLACED IN THE BATTERY CHARGER AND DURING CHARGING THE BATTERY IGNITED AND CAUGHT FIRE. THE CUSTOMER REMOVED THE POWER SUPPLY CABLE AND THE FIRE EXTINGUISHED SLOWLY. NOBODY WAS INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84753 | INTERA 1.5T POWER/PULSAR | LNH | PHILIPS HEALTHCARE - BEST NETHERLANDS | 781105 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |