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U.S. Department of Health and Human Services

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

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TOSHIBA MEDICAL SYSTEMS CORPORATION INFINIX DPI SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Back to Search Results
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.
 
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Brand NameINFINIX DPI
Type of DeviceSOLID 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 Key6777107
MDR Text Key82176065
Report Number6777107
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
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 Received08/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberINFINIX DPI
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/13/2017
Event Location Hospital
Date Report to Manufacturer07/13/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/09/2017 Patient Sequence Number: 1
Treatment
NO; NO OTHER THERAPIES
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