MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS

Catalog Number 10332185

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 04/22/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens has asked the customer to return the instrument and the power supply that was plugged in when they saw the smoke, for investigation.The customer has received a replacement instrument.The cause of this event is unknown.

Event Description

The customer reported that when the clinitek status was plugged in, it started smoking from the printer area.The customer states that there was no sparks or fire.The instrument was unplugged.There is no report of injury due to this event.

Manufacturer Narrative

Siemens evaluated the clinitek status returned by the customer.The instrument was returned in fair condition.It was missing the cap for the printer.The instrument was returned with a power supply, but it was a non-siemens part, which is the incorrect power supply for the clinitek status.No batteries were in the instrument.The instrument has a d16 damage on the main board.The d16 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).The instrument had been replaced and the customer is operational with the new instrument.

• Brand Name: CLINITEK STATUS
• Type of Device: CLINITEK STATUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10032548
• MDR Text Key: 190690908
• Report Number: 3002637618-2020-00020
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• PMA/PMN Number: K031947
• 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: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10332185
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1