MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK ADVANTUS

Catalog Number 10283060

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2022

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested that the instrument and power supply be returned for further evaluation.On may 3, 2022 siemens was informed that the customer shipped the instrument to the incorrect address and it cannot be retrieved, therefore no further investigation is possible.The customer is operational with a replacement instrument.The cause of this event is unknown.

Event Description

The customer reported that their clinitek advantus instrument was smoking from the printer.The customer stated they replaced the printer head but the instrument was still smoking.Siemens requested that the customer immediately unplug and cease use of the instrument.There is no report of injury due to this event.

• Brand Name: CLINITEK ADVANTUS
• Type of Device: CLINITEK ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 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 ; 62 flanders-bartly rd.; flanders, NJ 07836
• MDR Report Key: 14337250
• MDR Text Key: 294621508
• Report Number: 3002637618-2022-00018
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K063276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/09/2022

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: 10283060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1