MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS

Catalog Number 10332185

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems No Patient Involvement (2645); Not Applicable (3189)

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

The customer stated that a replacement system has been delivered to the site.The cause for this event is unknown.

Event Description

The customer reported that smoke was seen coming from the printer of the clinitek status when plugged in and powered up.It was immediately powered down and unplugged.There was no injury or flames reported due to this event.

Manufacturer Narrative

The investigation of the returned instrument showed that the failure was reproduced and was attributed to a failure of the d16 on the main pcb.D16 is the overvoltage protector diode, which blows if the voltage applied to the instrument is too high.The customer has received a new device and it is operational.

• 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: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 6772135
• MDR Text Key: 82043185
• Report Number: 3002637618-2017-00124
• 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: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

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: Medical Technologist
• Device Catalogue Number: 10332185
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/07/2017
• Supplement Dates Manufacturer Received: 08/30/2017
• Supplement Dates FDA Received: 09/22/2017
• 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