MAUDE Adverse Event Report: TOSHIBA MEDICAL SYSTEMS CORPORATION INFINIX DPI; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number INFINIX DPI

Device Problems Overheating of Device (1437); Loss of Power (1475); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Code Available (3191)

Event Date 07/05/2017

Event Type  malfunction  

Event Description

Past medical history of coronary disease, hypertension, acute myocardial infarction year ago.He underwent percutaneous coronary intervention in another hospital then.Recurrent chest pain prompted the referral to this hospital for coronary angiography.Procedure done on approximately two weeks ago: coronary angiography, left heart catheterization with successful percutaneous intervention to the total occlusion of the mid/distal right coronary artery (rca).Excerpts from operative report: just after i deployed the stent and removed the balloon, but before i could perform a cineangiography to confirm the result, all of a sudden the fluoro went dead in the room and i was unable to perform any fluoroscopy or cine.Hemodynamically the patient was stable.His pressure across the coronaries was around 110.His systolic pressure by the cuff was around 180.Obviously, the discrepancy in the pressure was due to the fact that i had a guiding catheter and a guide liner across the coronary.We waited a significant amount of time to see if there was recovery and the machine continued to register, but the device had overheated and because of that, i could not perform any fluoroscopy.The patient was stable throughout.He was not complaining of chest pain or shortness of breath.Pressures were around 105 to 110, st segment looked normal.Angiomax was still infusing.However, due to continuing loss of fluoroscopy we decided to transfer the patient to the room next door with everything on board.We transferred the patient to the next room while maintaining sterile status.We set up the room as best we could and then resumed the case.Patient did well post-procedure.Manufacturer response for fluoroscope, (brand not provided) (per site reporter).Communicated with (b)(4) will follow-up.

• Brand Name: INFINIX DPI
• Type of Device: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• Manufacturer (Section D): TOSHIBA MEDICAL SYSTEMS CORPORATION; paul biggins; 2441 michelle dr.; tustin CA 92780
• MDR Report Key: 6777107
• MDR Text Key: 82176065
• Report Number: 6777107
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: INFINIX DPI
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/13/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES
• Patient Age: 69 YR
• Patient Weight: 99