MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. CENTRALINK DATA MANAGEMENT SYSTEM; LABORATORY INFORMATION SYSTEM

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem No Apparent Adverse Event (3189)

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

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer site.The cse observed that the customer (operator) had positioned the monitor beyond the normal monitor placed position, and the power cable was damaged.The cse replaced the power cable, and the system was operational.The damaged power cable at the rear of the monitor was due to an unintended use error when moving the monitor beyond the cable length capability.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

Siemens was informed by the customer that an operator of the centralink data management system (centralink) received an electrical shock when they accidently touched a broken power cable at the rear of the monitor.The monitor had switched off, however when the operator plugged the power cable in the centralink monitor, and touched the damage point, an electrical shock was received.The operator did not seek medical treatment.There are no reports that treatment was prescribed or adverse health consequences due to the electrical shock received by the operator.

• Brand Name: CENTRALINK DATA MANAGEMENT SYSTEM
• Type of Device: LABORATORY INFORMATION SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; chapel lane, swords co.; registration #: 8020888; dublin, ; EI
• Manufacturer Contact: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 8549331
• MDR Text Key: 143066997
• Report Number: 2432235-2019-00151
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2019

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: CENTRALINK DATA MANAGEMENT SYSTEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 04/25/2019
• 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: Initial
• Patient Sequence Number: 1