MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC STREAMLAB ANALYTICAL WORKCELL

Model Number STREAMLAB ANALYTICAL WORKCELL

Device Problem Mechanical Problem (1384)

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

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument, the cse discovered that the relay was shorting and turning on heater continuously.The cse replaced the sealer.The cause of smoke being emitted from the instrument was due to faulty sealer.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The customer reported smelling "burning rubber" in their laboratory.When the customer opened the sealer cover of the streamlab core unit, smoke was emitted from the heater.The sealer module has been turned off.There are no reports of injury to staff, damage to property, or impact to patient samples.

• Brand Name: STREAMLAB ANALYTICAL WORKCELL
• Type of Device: STREAMLAB ANALYTICAL WORKCELL
• 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; val della torre, 10040 ; IT 10040
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 5978262
• MDR Text Key: 55679843
• Report Number: 1226181-2016-00462
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/26/2016

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: Health Professional
• Device Model Number: STREAMLAB ANALYTICAL WORKCELL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2016
• Initial Date FDA Received: 09/26/2016
• 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