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

Model Number STREAMLAB AUTOMATION

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

The uninterruptible power supply (ups) for the refrigerated storage module (rsm) of a stream lab automation system failed and emitted smoke.A siemens customer service engineer (cse) was performing service on the refrigerated storage module (rsm) of stream lab automation system.After replacing the fuse to a transformer and restoring power, the ups emitted smoke.The cse found that the battery in the ups had failed.The cause of the smoke was a failed ups battery.The instrument is performing within specification.No further evaluation of this device is needed.

Event Description

The uninterruptible power supply (ups) for the refrigerated storage module (rsm) of a stream lab automation system failed, and emitted smoke.There are no known reports of patient intervention, or adverse health consequences due to the event.

• Brand Name: STREAMLAB AUTOMATION
• Type of Device: STREAMLAB 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 givoletto 15; registration #: 3005509212; 10040 val della torre (torino), ; IT
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 10985002
• MDR Text Key: 220966650
• Report Number: 2517506-2020-00367
• Device Sequence Number: 1
• Product Code: CDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043546
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: STREAMLAB AUTOMATION
• Device Catalogue Number: 10444806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2020
• 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