MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER

Model Number	ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2020
Type of Reportable Event	Malfunction
Additional 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 removed the uninterruptible power supply (ups) from the advia 2120i hematology system with single aspirate autosampler.The cse verified that the advia 2120i hematology system with single aspirate autosampler was operational after removing the ups.The burning smell was emitted from the ups unit and not the advia 2120i hematology system with single aspirate autosampler.The ups unit contains two fuses which are designed to trip if there is a spike in power or an overload coming into the system.When these fuses are tripped there is normally an electrical smell associated and power coming in is cut-off.The cause of the event is the tripping of the fuses as designed.Siemens is investigating the cause of the electrical shock.
Event or Problem Description
The customer alleged they received an electrical shock and noticed a burning smell after turning on the uninterruptible power supply (ups) attached to the customer's advia 2120i hematology system with single aspirate autosampler.There are no reports of health consequences for the customer and the customer did not require medical treatment.Statements and actions attributed to the customer are derived from information submitted to the siemens complaint handling system and haven't been verified.
Additional Manufacturer Narrative
The initial mdr 2432235-2020-00325 was filed on 17-jun-2020.Additional information (09-jul-2020): the front panel that contains the on/off switch for the uninterruptable power supply (ups) as well as the on/off switch itself is plastic which would eliminate the possibility of electrical shock other than normal static.The cause of the reported electrical shock is unknown.The system is performing according to specifications.No further evaluation of this device is required.The result code and conclusion code in h6 were updated.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Common Device Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown, ny
• MDR Report Key: 10163727
• Report Number: 2432235-2020-00325
• Device Sequence Number: 11655933
• Product Code: GKZ
• UDI-Device Identifier: 00630414581965
• UDI-Public: 00630414581965
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K102644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2020

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
• Operator of Device: Health Professional
• Device Model Number: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10488923
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1