MAUDE Adverse Event Report: SIEMENS HELATHCARE DIAGNOSTICS AUTOSCAN-4

Model Number B1012-1R

Device Problem Device Inoperable (1663)

Patient Problem Not Applicable (3189)

Event Date 11/29/2014

Event Type  malfunction  

Event Description

It was reported that the instrument did not boot up.The customer replaced the fuse and did not work.The lamp was also replaced and the instrument did not turn on either.The customer was unsure whether the replacement fuse was new therefore a second fuse was used.When replacing the fuse for the second time, a smoke came out of the front of the instrument.The instrument was turned off and power was disconnected.

Manufacturer Narrative

(b)(4).Issue associated with the device being in a nonfunctional or inoperable state and cannot be used unless the cause of the inoperability are located and fixed.Siemens svc engineer replaced the defective power supply, power controller, and power supply fan.Instrument check was performed and passed post service.Qc diagnostics and calibration check was also performed and working as intended.No further action is required.

• Brand Name: AUTOSCAN-4
• Type of Device: AUTOSCAN-4
• Manufacturer (Section D): SIEMENS HELATHCARE DIAGNOSTICS; west sacramento CA
• Manufacturer Contact: jose untalan ; 2040 enterprise blvd.; west sacramento, CA 95691 ; 9163743031
• MDR Report Key: 4353633
• MDR Text Key: 17995953
• Report Number: 2919016-2014-00045
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B1012-1R
• Device Catalogue Number: B1012-1R/10461173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1