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 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens investigation of the returned clinitek status has been completed.The d16 was the source of the burning smell and smoking, but it is not a fire risk.The d16 fails when incorrect power is connected to the device, either through plugging in the wrong power supply (status uses a common barrel connector) or using 3.5v rechargeable batteries.The clinitek status specifies using common 1.5v aa batteries.The instrument has been replaced and the replacement is in service and fully functional.

Event Description

The customer reported that the power board in the clinitek status started smoking when a new power supply was used.There was no report of injury due to this event.

• Brand Name: CLINITEK STATUS
• Type of Device: CLINITEK STATUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: tim krauskopf ; 2 edgewater drive; norwood, MA 02062 ; 8622285388
• MDR Report Key: 8405585
• MDR Text Key: 139208926
• Report Number: 3002637618-2019-00027
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1