MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. CIOS ALPHA

Model Number 10308191

Device Problems Circuit Failure (1089); Electrical /Electronic Property Problem (1198)

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

Event Date 02/04/2015

Event Type  malfunction  

Event Description

The reported issue was found internally by siemens.The quick discharge function of the intermediate circuit is affected but a potentially defective crimping in the line circuit of the polydoros m25 on the cios alpha system.This may lead to the system not discharging as quickly as expected, thus posing hazard to service personnel.The service documentation describes all steps to discharge the capacitors.The service documentation includes the description of the led display of charge status, residual voltage measurings and a warning for residual voltage.If service personnel decide to ignore the led display and the measurings, an electric shock may occur leading to potentially serious injuries.The delivery of the polydoros m25 part has been stopped by siemens.No injuries attributed to this event have been reported.

Manufacturer Narrative

The reported issue is under investigation and a supplemental report will be submitted once additional info has been received.This report was filed march 3 2015.

• Brand Name: CIOS ALPHA
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 51 valley stream pkwy.; ms d-02; malvern PA 19355 140
• Manufacturer (Section G): SIEMENS AG; roentgenstrassa 19-21; kemnath 9547 8; GM 95478
• Manufacturer Contact: anastasia mason ; 51 valley stream pkwy.; ms d-02; malvern, PA 19355-1406 ; 6102194834
• MDR Report Key: 4589625
• MDR Text Key: 5341239
• Report Number: 2240869-2015-00734
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10308191
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other