MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+

Model Number 10379675

Device Problems Electrical /Electronic Property Problem (1198); Temperature Problem (3022)

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

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested the customer's instrument and batteries to be returned for investigation.A new instrument has been sent to the customer.

Event Description

The customer's instrument would not power on so they inserted batteries.When they turned the instrument on it started smoking.No flames were seen and there was no injury due to this event.

Manufacturer Narrative

Siemens evaluated the clinitek status returned by the customer.The instrument was returned in fair condition.The instrument was returned with the original power supply and batteries.The instrument has a d16 damage on the main board.The d16 on the main board was source of the burning smell but it is not a fire risk.D16 fails 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).In addition this can be caused by a natural event causing a power surge.

• Brand Name: CLINITEK STATUS+
• Type of Device: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 10504191
• MDR Text Key: 206822711
• Report Number: 3002637618-2020-00046
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 00630414574639
• UDI-Public: 00630414574639
• Combination Product (y/n): N
• PMA/PMN Number: K091216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• 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
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1