MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY COROSKOP HI-P; SYSTEM, XRAY ANGIOGRAPHIC

Model Number 06379759

Device Problem Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/28/2014

Event Type  malfunction  

Manufacturer Narrative

Siemens conducted an investigation of the affected components, however, a root cause could not be determined.After replacement of the components, the system is operating normally.The coroskop hi-p system was introduced into the market from 1993-2001.Technical support for this product ended in 2013.(b)(6).

Event Description

It was reported to siemens that the anode rotation module n75 was replaced 3 times, however the ic's j4 and j6 of the d761 board were burned within 5 minutes of activating the system.The customer did not report any impact to the state of health of the patient.The system was manufactured in 1994 and technical support for this system ended in 2013.

• Brand Name: COROSKOP HI-P
• Type of Device: SYSTEM, XRAY ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 5438283
• MDR Text Key: 38856888
• Report Number: 2240869-2016-00358
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K940484
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 06379759
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/16/2016
• Initial Date FDA Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/1994
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention