MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC STREAMLAB CORE UNIT

Model Number STREAMLAB CORE UNIT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burn(s) (1757)

Event Date 04/19/2015

Event Type  No Answer Provided  

Event Description

A lab technologist was burned by a soldering iron which was being used by a siemens customer service engineer (cse).The cse was repairing a component on the streamlab core unit when the technologist approached the cse to discuss something.During this interaction, the technologist's finger made contact with the soldering iron.The technologist went to an emergency room.It is unknown if any treatment was required for the burn.

Manufacturer Narrative

A siemens customer care center (ccc) specialist contacted the cse about the incident.The cse informed the ccc that the burn was minor.

• Brand Name: STREAMLAB CORE UNIT
• Type of Device: STREAMLAB CORE UNIT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; brookfield CT 06804
• Manufacturer (Section G): INPECO S.P.A.; registration #: 3005509212; via givoletto 15; 10040 val della torre (torino) ; IT
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 4771494
• MDR Text Key: 5777406
• Report Number: 1226181-2015-00254
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: STREAMLAB CORE UNIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2015
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 60 YR