MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+; CT STATUS+

Catalog Number 10379675

Device Problems Failure to Power Up (1476); Smoking (1585)

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

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

Siemens is in process of investigating customer returned connect platform.The cause for the event is unknown at this moment.

Event Description

Customer reported that when they went to power on the instrument for the first time, it would not power on.They put 6 aa duracell batteries in the instrument with the connect ((b)(4)) and the instrument started to smoke up from the bottom and up the sides.There was no report of injury due to this event.

Manufacturer Narrative

Investigation of the instrument determined that the root cause was a catastrophic failure of d16 on the main pcb.D16 is the overvoltage protector diode, which blows if the voltage applied to instrument is too high.Customer's instrument was replaced and customer is now operational.There is no evidence that a siemens product is not meeting specifications.

• Brand Name: CLINITEK STATUS+
• Type of Device: CT STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 5134786
• MDR Text Key: 28172064
• Report Number: 1217157-2015-00144
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 02/22/2016

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: No Information
• Device Catalogue Number: 10379675
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1