MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC ARTIS ZEE; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number ARTIS ZEE

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 04/23/2015

Event Type  malfunction  

Event Description

X-ray tube that was replaced one month ago due to a recall stopped working during a case.A complete reboot of the system failed to correct the issue, and a portable c-arm x-ray machine had to be brought into the room to complete the procedure.The patient remained on the table for approximately 15 minutes and could not receive post deployment dilation while the trouble shooting was taking place.
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manufacturer response for interventional angiography system, artis zee ceiling interventional angiography system (per site reporter).
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manufacturer installed the tube due to a mandatory fmi.

• Brand Name: ARTIS ZEE
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC; 51 valley stream parkway; malvern PA 19355
• MDR Report Key: 4751522
• MDR Text Key: 5774902
• Report Number: 4751522
• Device Sequence Number: 1
• Product Code: IZI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: ARTIS ZEE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2015
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR