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 04/17/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.The cse stated the instrument is two to three feet from a workstation counter and there is very little room to walk in front of the instrument, making it easy to kick the panel which would result in it falling.The cse indicated the same panel fell off the previous day, hitting an operator's foot but not resulting in any injury.The panel was secure and safe.The cse adjusted the io cover and cover to the right of decapper cover magnets.The instrument was returned to customer.Service placed an order for one magnet for the end cover and will return upon arrival for installation.The cause of the panel falling off is unknown.Siemens is investigating this issue.

Event Description

The left input/output (io) panel on the streamlab core unit fell off and landed on the finger of a medical technologist.The technologist was taken to the emergency room and was diagnosed with a broken finger.The customer secured the panel.

Manufacturer Narrative

The initial mdr 1226181-2016-00285 was filed on may 16, 2016.Additional information (05/19/2016): the siemens customer care center (ccc) contacted the customer.The customer stated that when the operator kicked the input output panel, it fell off.When the operator was placing the panel back on, they dropped it and it fell on their finger, causing the injury.A siemens customer service engineer (cse) returned to the customer site.The cse reinforced magnetics applied with heavy duty velcro strips to both panels.The cse stated that the space between the streamlab and the workstation is less than two feet.A siemens headquarter support center (hsc) specialist evaluated the event.The hsc specialist stated that drawings that are given to the customer require a minimum of three feet.Hsc recommended that the customer is trained to hold the panels from the top to place into position, to avoid an injury.The cause of the panel falling off was due to the operator kicking it, due to insufficient clearance.The cse secured the panel.The instrument is performing according to 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 INC; 101 silvermine road; brookfield CT 06804
• Manufacturer (Section G): INPECO S.P. A; registration #: 3005509212; via givoletto 15; val della torre, 10040 ; IT
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 5658331
• MDR Text Key: 45283034
• Report Number: 1226181-2016-00285
• 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,Followup
• Report Date: 06/13/2016

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: 04/18/2016
• Initial Date FDA Received: 05/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1