FDA Adverse Event Other Summary report: N

INTERA 1.5T MASTER/NOVA

MDR report key: 1872648 · Received September 27, 2010

Report

Report Number: 3003768277-2010-00208
Event Type: Other
Date Received: September 27, 2010
Date of Event: September 9, 2010
Report Date: September 10, 2010
Manufacturer: PHILIPS MEDICAL SYSTEMS
Product Code: LNH
PMA / PMN Number: K001796
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCLUSIONS: THE ECG MONITORING EQUIPMENT (GE DATEX OHMEDA) USED DURING THE MR EXAMINATION WAS NOT PROVIDED BY PHILIPS HEALTHCARE. ALTHOUGH THIS EQUIPMENT IS MARKED AS MR COMPATIBLE BY THE SUPPLIER, THE EQUIPMENT WAS NEVER TESTED OR RELEASED FOR A PHILIPS MR SYSTEM. HENCE, THERE IS STILL THE POSSIBILITY THAT THE ECG LEADS/PADS MAY HEAT UP LOCALLY DUE TO RF INTERFERENCE. THIS KIND OF INCIDENT CAN BE PREVENTED BY USING ECG LEADS PROVIDED BY PHILIPS HEALTHCARE AND FOLLOWING THE INSTRUCTIONS FOR USE (IFU). THE INSTRUCTIONS FOR USE ALREADY CONTAIN WARNINGS ONLY TO USE ECG LEADS PROVIDED BY PHILIPS HEALTHCARE. THE USE OF OTHER TYPES OF ECG LEADS MAY CAUSE HEATING OF THE SKIN. THEREFORE, NO FURTHER CORRECTIVE ACTION IS REQUIRED FOR THIS SITE. THIS INCIDENT REPORT WILL BE FORWARDED TO THE MANUFACTURER OF THE ECG MONITORING EQUIPMENT.

Description of Event or Problem · 1

THE PATIENT HAD A MR EXAM. SHE WAS UNDER GENERAL ANESTHETIC. SHE HAD ECG LEADS ATTACHED TO HER FROM THIRD PARTY EQUIPMENT, GE DATEX OHMEDA. IMMEDIATELY AFTER THE EXAMINATION, THE PATIENT HAD A LARGE BURN WITH BLISTERS AT THE MID LINE OF THE ABDOMEN DIRECTLY UNDER THE ECG LEADS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INTERA 1.5T MASTER/NOVA	LNH (MAGNETIC RESONANCE DIAGNOSTIC DEVICE)	LNH	PHILIPS MEDICAL SYSTEMS	781106	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other