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 11/24/2021

Event Type  malfunction  

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.

Event Description

The customer reported that their clinitek status+ would not turn on after it was moved.The smell of smoke was produced.They inserted batteries and smoke came out of the instrument.No fire was observed.The batteries were removed immediately.There was no report of injury due to this event.

Manufacturer Narrative

Siemens has completed the investigation.The instrument was returned with the appropriate power supply but without the batteries that were said to be in use at the time of the event.The d16 on the main board was the source of the light smoke produced, but it is not a fire risk due to plastics being 94v0.D16 fails when an 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).In addition, this can be caused by any natural event causing a power surge.

• 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: 13019066
• MDR Text Key: 282344154
• Report Number: 3002637618-2021-00073
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 01/18/2022
• Supplement Dates FDA Received: 01/24/2022
• 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