MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+

Catalog Number 10379675

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested the customer return the instrument and batteries for investigation.The cause of the event is unknown.

Event Description

The customer reported that their clinitek status+ would not power on.They tried a different power cord and outlet and still no power.When they inserted batteries, the instrument started to smoke from the casing of the instrument, behind the display.The customer stated there were no flames or injuries.

Manufacturer Narrative

Investigation completed: the clinitek status was returned in good condition with no damage to the exterior of the instrument.The correct power supply was returned but no batteries were returned.The instrument has d16 damage on the main board.D16 failure caused system to not operate.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).

• Brand Name: CLINITEK STATUS+
• Type of Device: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8949859
• MDR Text Key: 159232128
• Report Number: 3002637618-2019-00098
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10379675
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1