MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS STREAMLAB ANALYTICAL WORKCELL

Model Number STREAMLAB ANALYTICAL WORKCELL

Device Problem Fire (1245)

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

Event Date 02/20/2014

Event Type  malfunction  

Event Description

The customer reported seeing smoke coming from the streamlab core unit centrifuge.No one was injured or treated for smoke inhalation.There were no reports of any medical intervention due to the smoke.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site for instrument evaluation.The cse determined that the cause of the smoke was due to a malfunction in the varister relay located on the centrifuge control printed circuit board.The cse replaced the printed circuit board and confirmed that the system was functioning properly.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: STREAMLAB ANALYTICAL WORKCELL
• Type of Device: STREAMLAB ANALYTICAL WORKCELL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 101 silvermine road; brookfield CT 06804
• Manufacturer (Section G): INPECO S.P. AVIA G. DI VITTORIO VIA G. DI VITTORIO; 11 i-20090 segrate; registration # 3005509212; IT
• Manufacturer Contact: john nelson ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 3687124
• MDR Text Key: 4302223
• Report Number: 1226181-2014-00146
• 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: 02/20/2014

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: 02/20/2014
• Initial Date FDA Received: 03/19/2014
• 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