MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS Q BIPLANE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10848282

Device Problems No Display/Image (1183); Arcing (2583); Unexpected Shutdown (4019)

Patient Problems Apnea (1720); Cardiopulmonary Arrest (1765)

Event Date 06/19/2020

Event Type  malfunction  

Event Description

During stenting of lad, loss of imaging and hemodynamic monitoring on all imaging monitors in cath lab 3.Patient developed asystole and apneic, cpr instituted, code blue.Pt was intubated and moved to cath lab 1.Cath lab 3 was closed for further investigation into imaging going down.The case started with good picture at the beginning, then the signal failed would explain the grainy picture witnessed by the users as the case continued.The cathode side of the cable had a definite indication of arcing located under the system cabinet behind nurse station.A shut down error message did appear on screen however was only on screen for short amount of time before machine shut down.Biomed check with siemens.Per biomed check - siemens engineer found arcing at one of the high-tension cables in the system cabinet.This arcing could be heard when tech was troubleshooting the discrepancy.The condition caused a high resistance short circuit which would cause signal degradation during pulsing associated with the fluoroscopy type of case.High resistance shorts can be intermittent and can also slowly cause signal degradation.A new high-tension cable was installed by siemens engineers.The system was then calibrated.

• Brand Name: ARTIS Q BIPLANE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 10337576
• MDR Text Key: 200800577
• Report Number: 10337576
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10848282
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2020
• Event Location: Other
• Date Report to Manufacturer: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27740 DA