MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK STATUS+

Catalog Number 10379675

Device Problem Smoking (1585)

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

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

The customer was told to unplug the unit and keep it off.The instrument has been requested for return for investigation.A replacement instrument has been sent to the customer.The cause of this event is unknown.

Event Description

The customer reported that their status+ instrument smelled of smoke when powering one.After cycling the instrument off and on again, the customer saw smoke coming from the printer.There is no report of injury due to this event.

Manufacturer Narrative

The customer returned their system to siemens for physical inspection and investigation.The investigation was completed.A component on the main board was the source of the smoke, but it is not a fire risk.The d16 component can fail for over voltage protection when incorrect power is connected to the device, either through plugging in the wrong power supply (device uses a common barrel connector) or using 3.5v rechargeable batteries (device specifies using common 1.5v aa batteries).This can also be caused by any natural event which causes a power surge.Instrument is operating as intended.

• Brand Name: CLINITEK STATUS+
• Type of Device: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; northern road; chilton industrial estate; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 18803309
• MDR Text Key: 337527657
• Report Number: 3002637618-2024-00015
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

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 Catalogue Number: 10379675
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 04/15/2024
• 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
• Type of Device Usage: A
• Patient Sequence Number: 1