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 09/14/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument, it was discovered the panel's safety cable was missing.It is unknown how or when the cable was removed.The hinges have been inspected and are in place and working properly.The latches at the top of the door have been replaced and adjusted to hold the door in the proper position.The cse installed the safety cable on the instrument.The cause of the panel falling off was due to a missing safety cable.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A streamlab core unit center input/output panel broke off and fell on an operator's ankle, scraping it.The operator went to the emergency room, and had her ankle x-rayed.The x-ray showed no visible evidence of tendon damage other than possible bruising.The operator was released.The operator was previously scheduled for an ankle replacement surgery, and had to consult with her physician to ensure the tendon was undamaged so that her surgery may proceed.Upon follow up, the operator confirmed that the tendon was only bruised and her ankle replacement surgery may proceed as previously scheduled.There were no adverse events due the streamlab panel falling and scraping an operator's ankle.

• 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 avenue; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6010855
• MDR Text Key: 56918703
• Report Number: 1226181-2016-00466
• 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: 10/07/2016

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: 09/14/2016
• Initial Date FDA Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1