MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY ARTIS ZEE CEILING; SYSTEM, XRAY, ANGIOGRAPHIC

Model Number 10094137

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 10/06/2015

Event Type  malfunction  

Manufacturer Narrative

An investigation is underway and a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.This event occurred in (b)(6).

Event Description

It was reported to siemens that during a procedure on the artis zee ceiling system, a breakdown of the transformer occurred, resulting in a delay of procedure and the patient examination lasting longer than expected.There is no report of impact to the state of health of the patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The generator did detect an error in the high voltage transformer due to activation of the pressure switch.The generator is switching the high voltage off to prevent adverse effects, therefore, x-ray imaging is inhibited.The generator status resets when the pressure switch is deactivated.The possibility exists for a delay in procedure due to the unavailability of x-ray imaging as the pressure switch is activated.Exchange of the affected parts was performed according to the relevant sections of the service documentation.

• Brand Name: ARTIS ZEE CEILING
• 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: 5433313
• MDR Text Key: 38751148
• Report Number: 2240869-2016-00605
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K073290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 02/01/2016

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: 10094137
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2016
• Initial Date FDA Received: 02/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2008
• 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