MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 120 WITH AUTOSAMPLER

Model Number ADVIA 120 WITH AUTOSAMPLER

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer site.The cse determined that the advia 120 hematology system's uninterruptible power supply (ups) had failed internally and was smoking.The cse unplugged the ups from the wall and from the analyzer and replaced it with a new ups.The cause of the ups failure was due to the multiple power surges in the lab.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

The customer observed smoke and an electrical burning smell coming from the back of their advia 120 hematology system by the outlet plug after having several power surges in their lab.No flames were observed and there are no reports of delays in patient testing.There are no reports of adverse health consequences due to this event.

• Brand Name: ADVIA 120 WITH AUTOSAMPLER
• Type of Device: ADVIA 120 WITH AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; registration number: 8020888; chapel lane, swords, co.; dublin, ; EI
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145242740
• MDR Report Key: 10889378
• MDR Text Key: 217884728
• Report Number: 2432235-2020-00459
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414574868
• UDI-Public: 00630414574868
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971998
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 120 WITH AUTOSAMPLER
• Device Catalogue Number: 10360958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2020
• 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