MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY COMPUTER, DIAGNOSTIC, PROGRAMMABLE; SENSIS XP

Model Number 6623974

Device Problem Image Display Error/Artifact (1304)

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

Event Date 01/08/2016

Event Type  malfunction  

Manufacturer Narrative

The event is currently under investigation and a root cause has not yet been determined.A supplement report will be filed at the close of the investigation.This event occurred in (b)(6).

Event Description

It was reported to siemens that when an ablation is started, all ecg lines are shifted out of the screen.When ablation is stopped, the image is fine again.The procedure was not able to be completed.The customer did not report any impact to the state of health of the patient involved.

Manufacturer Narrative

Following completion of an investigation, it was determined that the ablation cable was previously damaged and improperly repaired.It is unknown who performed the previous repair.The reported problem was not caused by the system and measures were take to sufficiently solve the problem to prevent recurrence.

• Brand Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Type of Device: SENSIS XP
• 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: 5416116
• MDR Text Key: 38368283
• Report Number: 2240869-2016-30683
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150493
• 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: 01/15/2016

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: 6623974
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2016
• Initial Date FDA Received: 02/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2015
• 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