MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+ USA

Model Number 10379675

Device Problem Smoking (1585)

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

Event Date 12/01/2021

Event Type  malfunction  

Event Description

The customer reported that their clinitek status+ would not power on.They tried another power adapter and a new outlet without success.After inserting batteries, the instrument became very hot and light smoke started coming from the printer area.After removing the batteries the smoke stopped.There is no report of injury from this event.

Manufacturer Narrative

Siemens has asked for the instrument to be returned for investigation.No one was harmed by this smoking analyzer and no property was damaged.The customer is getting a replacement system.The cause of this event is unknown.

Manufacturer Narrative

Siemens has completed the investigation of the customer's returned instrument and power supply.The investigation of the returned instrument determined that the cause of the issue was due to a failure of the d16 on the main pcb.D16 is the overvoltage protector diode, which blows if the voltage applied to the instrument is too high.The power supply returned with the instrument is not the siemens power supply.The customer is operational with a replacement instrument.

• Brand Name: CLINITEK STATUS+ USA
• Type of Device: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 511 benedict avenue; tarrytown, NY 10591
• MDR Report Key: 13009284
• MDR Text Key: 282261569
• Report Number: 3002637618-2021-00072
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 00630414574639
• UDI-Public: 00630414574639
• 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: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

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: 10379675
• Device Catalogue Number: 10379675
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 01/10/2022
• Supplement Dates FDA Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1