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

Catalog Number	10379675
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has requested the instrument and power supply to be returned as well as more information for further investigation.The cause of this event is unknown.
Event or Problem Description
The customer stated that there was visible smoke coming from their clinitek status+.No flames were seen.There is no report of injury due to this event.
Additional Manufacturer Narrative
Siemens showed due diligence in attempting to obtain additional information regarding the return of the product.However, to date, there have not been any additional updates on the return.Without the requested product, the investigation could not proceed.The d16 component can fail 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.This can cause some smoke to appear, but it is not a fire risk.However, without the return of this instrument this cannot be confirmed.The cause of this event is unknown.
Additional Manufacturer Narrative
Upon investigation, evidence of voltage overload on the main board was identified.Specifically, the d16 diode was damaged.When a d16 component fails, the contents on the inside may appear as smoke.Furthermore, d16 fails when an incorrect power source is connected to the device, through plugging in the wrong power supply or this can be caused by any natural event causing a power surge.Although damage to the d16 diode was identified, the source of the high voltage cannot be determined with the information provided.The d16 on the main board was the likely source of the light smoke produced, but it is not a fire risk due to plastics being 94v0.The recommendation from siemens is to ensure that appropriate power source is used, or to use a power conditioner to prevent uninterrupted power or surges.

• Brand Name: CLINITEK STATUS+
• Common Device Name: 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: 19180547
• Report Number: 3002637618-2024-00046
• Device Sequence Number: 17962015
• Product Code: JIL
• UDI-Device Identifier: 00630414574639
• UDI-Public: 00630414574639
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K091216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 10379675
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: Not provided; 05/28/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/13/2024; 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown