MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTRALINK DATABASE MANAGEMENT SYSTEM.

Model Number ADVIA CENTRALINK DATABASE MANGEMENT SYSTEM

Device Problem Mechanical Problem (1384)

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

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center to report that the facility's advia centralink database management system (centralink) fell off a shelf, hitting an operator on the head.A siemens customer service engineer (cse) was dispatched to the customer site.The cse found that the operator was holding on to the shelf of a cart with wheels while bending down to get an object that fell.One of the wheels broke causing the table to fall at an angle and allowing the centralink to fall off the shelf.This is an isolated event.The cause of the centralink falling and injuring an operator is a use error of using a shelf as a support while retrieving an object that fell.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

A centralink database management system fell off a shelf, hitting an operator on the head.The operator was taken to an emergency room (er) for evaluation.An er nurse closed the head wound with an adhesive bandage.There are no reports of adverse health consequences due to the centralink falling off a shelf and injuring an operator.

• Brand Name: ADVIA CENTRALINK DATABASE MANAGEMENT SYSTEM.
• Type of Device: CENTRALINK
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; registration #: 8020888; chapel lane; swords, co, dublin, 10040 ; EI 10040
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 8203320
• MDR Text Key: 132438214
• Report Number: 2432235-2018-00467
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2018

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 CENTRALINK DATABASE MANGEMENT SYSTEM
• Device Catalogue Number: 10816521
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/28/2018
• 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