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 09/06/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested the instrument and batteries to be returned for investigation.The instrument has been received but the batteries were not included.A replacement clinitek status+ has been sent to the customer.

Event Description

The customer reported their clinitek status+ would not turn on.The operator removed the power cord and installed batteries.Then powered on the instrument with the power button and it turned on.Soon after, the operator saw and smelled smoke coming out from the area under the printer cover.There were no flames and no injuries.The customer was instructed to leave the instrument off.

Manufacturer Narrative

The clinitek status+ was returned in good condition with no damage to the exterior of the instrument.The instrument was returned without a power supply or batteries.The instrument has d16 damage on main board.D16 failure caused the 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).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 10591
• MDR Report Key: 9110126
• MDR Text Key: 160022106
• Report Number: 3002637618-2019-00102
• 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: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• 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: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1