MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP; CLINICAL CHEMISTRY ANALYZER

Model Number ADVIA CENTAUR XP

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2014

Event Type  malfunction  

Event Description

The operator of an advia centaur xp instrument dropped a cuvette and attempted to retrieve the cuvette using a screwdriver.The screwdriver made contact with the cuvetter loader global input output board and the operator received an electrical shock.The operator went to a nearby emergency room (er), where an electrocardiogram (ekg) was performed.The operator was dismissed from the er without injuries.There are no reports of patient intervention or adverse health consequences due to the operator receiving an electric shock.

Manufacturer Narrative

The customer contacted the siemens technical solutions center (tsc).Upon follow-up, the customer stated that after evaluation in the emergency room he returned to work.When the operator contacted the global input output board with the screwdriver, he shorted it.The cause of the operator receiving a shock from the instrument was due to a human factors issue.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; registration number: 8020888; manufacturing limited; chapel lane, dublin, swords, co. ; EI
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown 10591 ; 9145242687
• MDR Report Key: 3667941
• MDR Text Key: 4202148
• Report Number: 2432235-2014-00209
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971418
• 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: 02/12/2014

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: ADVIA CENTAUR XP
• Device Catalogue Number: 078-A011-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2014
• Initial Date FDA Received: 03/07/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/02/2012
• 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