VNGRD BRST MRI TBLTP COIL 16-CH 3.0T

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL ONGOING FOR THIS EVENT. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

Description of Event or Problem

HOSPITAL SENT AN EMAIL TO GE SALES STATING: THEY JUST RECEIVED A CALL FROM A PATIENT THAT SAYS SHE HAD A MRI OF THE BREAST WITH THEM ABOUT A WEEK AGO THAT CAUSED HER TO HAVE SEVERE PAIN IN HER CHEST. HER PHYSICIAN JUST ORDERED A CHEST X-RAY THAT DEMONSTRATES THAT SHE HAS A RIB FRACTURE.

Additional Manufacturer Narrative

SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

Additional Manufacturer Narrative

ON (B)(6) OUR CUSTOMER (GE) WAS NOTIFIED THAT A PATIENT HAD GONE TO THEIR LOCAL PHYSICIAN AFTER AN MRI COMPLAINING ABOUT CHEST PAINS. THE DR. REQUESTED CHEST X-RAYS WHICH INDICATE PATIENT HAD A RIB FRACTURE. THIS WAS THEN REPORTED BACK TO THE SITE, AT WHICH POINT GE WAS NOTIFIED. THE ONLY INFORMATION THAT WAS GIVEN REGARDING THE EVENT THAT OCCURRED, WAS THE SITE WHERE THE INCIDENT HAPPENED AND THE EQUIPMENT (MAGNET AND COIL) THAT WAS IN USE. SINCE THE EVENT TOOK PLACE, BOTH PARTIES GE AND OURSELVES (INVIVO) HAVE MADE CALLS THAT HAVE GONE UNANSWERED AND EMAILS THAT THEY WOULD NOT REPLY TO THE REQUESTS REGARDING THE INCIDENT. ONLY COMMUNICATION SITE WOULD RESPOND TO IS THAT THEY WERE CONCERNED REGARDING HIPPA VIOLATIONS. BASED ON THE INFORMATION PROVIDED BY THE SITE, WE (INVIVO) DID A REVIEW OF THE HISTORICAL DATA FOR THIS COIL FAMILY TYPE AND HAVE FOUND NO ADDITIONAL FAILURES OF THIS KIND. ADDITIONALLY DESIGN WAS REVIEWED AND PROVIDED THE SITE USED THE COIL AS INTENDED, NO FAILURE COULD BE DETERMINED TO BE CONTRIBUTED BY THE COIL ITSELF. DEVICE AND INFORMATION REQUEST TO SITE, BUT NO INFORMATION WAS GIVEN NOR DEVICE RETURNED FOR EVALUATION.

Description of Event or Problem

GE RECEIVED A COMMUNICATION FROM A HOSPITAL THAT A PATIENT REPORTED A BROKEN RIB ROUGHLY A WEEK AFTER THE MRI SCAN. THE PATIENT INDICATED TO THEIR PERSONAL PHYSICIAN THAT THEY WERE EXPERIENCING CHEST PAINS. THE PATIENTS PHYSICIAN ORDERED CHEST X-RAYS, WHICH INDICATED THE PATIENT HAS A RIB FRACTURE.