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

Model Number APTIO AUTOMATION

Device Problem Temperature Problem (3022)

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

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens to report smoke and flame occurred inside the power distribution cabinet of an aptio automation instrument.A siemens customer service engineer (cse) was dispatched to inspect the instrument.The cse found a damaged 24 volt, 20 amp auxillary aptio track power supply located inside the power distribution cabinet of the aptio automation instrument.The cse replaced the power supply, resolving the issue.The damaged power supply was not returned to siemens for investigation.There are no known reports of patient intervention or adverse health consequences to the operator(s) or the environment due to the smoke and flame inside the power distribution cabinet.This is an isolated event.The instrument is performing within specifications.No further evaluation of this device is needed.

Event Description

The customer contacted siemens to report smoke and flame occurred inside the power distribution cabinet of an aptio automation instrument.There was a delay in processing samples on the track of approximately four hours due to the event.There are no known reports of patient intervention or adverse health consequences to the operator(s) or environment due to the smoke and flame inside the power distribution cabinet.

• Brand Name: APTIO AUTOMATION
• Type of Device: APTIO AUTOMATION
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• 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 10591 ; 9145243102
• MDR Report Key: 9475189
• MDR Text Key: 191177833
• Report Number: 2517506-2019-00468
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/16/2019

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: 10703031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/16/2019
• 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