MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+

Catalog Number 10379675

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2019

Event Type  malfunction  

Manufacturer Narrative

The instrument and batteries have been requested for investigation.A new instrument has been sent to the customer.The cause of this event is unknown.

Event Description

The customer reported that their clinitek status+ did not power on.Siemens service instructed the customer to unplug the unit and install new batteries.Once the batteries were installed, the customer attempted to turn the unit on and then smelled smoke.While removing the batteries the customer noticed smoke coming from the batteries.Service was not able to determine if the batteries were installed properly and had the customer remove the batteries.A new clinitek status+ will be provided to the customer.There was no report of injury due to this event.

Manufacturer Narrative

Siemens tech ops has completed the investigation.The failed battery causing the battery holder to melt was the source of the burning smell, but is not a fire risk.This failure could have occurred due to the use of incorrect, expired or rechargeable batteries.It is specified that the status shall be used with common 1.5v aa batteries.Batteries outside of the specified type can be susceptible to thermal runaway, causing the battery to generate excess heat eventually resulting in the melting of the surrounding plastic.The customer stated that they are fully functional, and the unit is back in service.

• Brand Name: CLINITEK STATUS+
• Type of Device: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8663174
• MDR Text Key: 146937906
• Report Number: 3002637618-2019-00065
• 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: 07/11/2019

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 Catalogue Number: 10379675
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 06/03/2019
• Supplement Dates Manufacturer Received: 07/02/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1