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 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

The customer has received a new unit and has returned the clinitek status+ to siemens for investigation.The cause of this event is unknown.

Event Description

The customer reported that their clinitek status+ began to emit a burning smell after attempting to power it on.Upon inserting new batteries, their system wouldn't start and began to emit visible smoke.There were no visible flames.Their was no report of harm to the operator or anyone else and no damage to any property.

Manufacturer Narrative

Siemens has completed the investigation: the instrument was returned as an instrument only.No batteries or power supply were returned with the instrument.The d16 on the main board was the 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 any natural event causing a power surge.When opening the clinitek status+, faint smoke stains were noted on the plastics directly above component d16.In addition, failure of d16 was confirmed using a multimeter.

• Brand Name: CLINITEK STATUS+ USA
• Type of Device: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 12033063
• MDR Text Key: 257181240
• Report Number: 3002637618-2021-00040
• 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: 07/01/2021

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
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1