MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. APTIO AUTOMATION BY SIEMENS

Model Number APTIO AUTOMATION

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) observed sparks while replacing an electrical relay for the bulk input module (bim) on an aptio automation system.The aptio automation system was under the control of a siemens customer service engineer (cse) at the time of the event.There was no report of smoke or flame.There was no delay in processing samples.The spark was caused by the installation of an incorrect part number relay in the bim.The cse obtained the correct part and installed it without issue.The instrument is performing within specifications.No further evaluation of this device is needed.

Event Description

On (b)(6) 2020 a siemens customer service engineer (cse) observed sparks while replacing an electrical relay for the bulk input module (bim) on an aptio automation system.There was no report of smoke or flame.There was no delay in processing samples on the aptio automation system.There are no known reports of patient intervention, or adverse health consequences due to the observed sparks.

• Brand Name: APTIO AUTOMATION BY SIEMENS
• Type of Device: APTIO AUTOMATION
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark, de
• Manufacturer (Section G): INPECO S.P.A; via torraccia 26; registration #: 3010825766; novazzano, 6883 ; SZ 6883
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, ny ; 5243102
• MDR Report Key: 9687462
• MDR Text Key: 194784152
• Report Number: 2517506-2020-00049
• Device Sequence Number: 1
• Product Code: LXG
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 02/10/2020

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
• Device Operator: Health Professional
• Device Model Number: APTIO AUTOMATION
• Device Catalogue Number: 10713760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1