MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 560 HEMATOLOGY SYSTEM

Model Number ADVIA 560 HEMATOLOGY SYSTEM

Device Problem Device Handling Problem (3265)

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

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

A siemens healthcare diagnostics (siemens) customer service engineer (cse) burned the laser connector and low level data acquisition (lsdaq) printed circuit board (pcb) while replacing a hardware block on the advia 560 hematology system.The laser connector and lsdaq pcb were burned because the voltage supply cable was crimped between the assembly when the cse replaced the hardware block.This shorted the circuit on the pcb.A siemens headquarters support center (hsc) further analyzed the event and determined that the connector metal portion of the system's body shorted in the area from the pcb to the metal frame.This short created a residual black mark on the system.The residual black mark on the system was potentially caused by a capacitor shorting out.The cause of the event is use error.The cse replaced the lsdaq pcb and the system is performing according to specifications.No further evaluation of this system is required.

Event Description

A siemens healthcare diagnostics (siemens) customer service engineer (cse) burned the laser connector and low level data acquisition (lsdaq) printed circuit board (pcb), during a troubleshooting process, on the advia 560 hematology system.A burning smell was emitted from the system.No smoke or flames were observed due to these burnt components.There are no known reports of adverse health consequences due to the burning smell that emitted from the advia 560 hematology system.

• Brand Name: ADVIA 560 HEMATOLOGY SYSTEM
• Type of Device: ADVIA 560 HEMATOLOGY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): DIATRON MI PIC; tablas str. 39; registration #: 3009297077; budapest, H-109 7; HU H-1097
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 7237856
• MDR Text Key: 99776936
• Report Number: 2432235-2018-00050
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414601816
• UDI-Public: 00630414601816
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K112755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 560 HEMATOLOGY SYSTEM
• Device Catalogue Number: 11170842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2017
• 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