MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS DCA VANTAGE PACKED INST USA

Model Number 10282969

Device Problem Smoking (1585)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

The customer indicated that the original power cord that came with the instrument was being used at the time of the event.The customer plugs the instrument directly into the wall, no adapter, battery backup unit or conditioner is used.The outlet was not causing the smoke, nor was it impacting other devices after the fact.The customer will receive a replacement system and the defective one will be returned for investigation.No injury or damage to property occurred.The cause of the event is unknown.

Event Description

The customer reported that they saw smoke coming from their dca vantage analyzer.The analyzer was immediately unplugged.There was a strong burning smell present at the power cord.No flames were seen, but smoke was visible.No sample was being run at that time.There was no report of injury to any patient or operator due to this event.

Manufacturer Narrative

Siemens has completed the investigation: the customer's system was investigated and the root cause of the smoke cannot be determined.The system was visually inspected and there was no evidence of damage.The printer head was clear without any evidence of a jam.Upon powering up the system, all components were operational.The display was functional, the fan was running, the motor homed to the correct location and the heater plate was operational.No smoke or odor was observed.There was what appeared to be a dried alcohol wipe within the cartridge compartment that was also discolored.While it is not clear why there was a wipe inside the cartridge compartment, it should be noted that objects should not be placed inside this compartment unless it is a lint-free wipe for regular maintenance.The operators guide does not instruct the user to leave any cloth or wipe inside the system when not in use.The reason for the smoke observed by the customer could not be verified and therefore the issue cannot be confirmed as a systemic product problem.The customer should use this event as a training opportunity to ensure no foreign objects are placed within the cartridge compartment as it has the potential to impact the analyzer optics.The customer is operational with a new system.

• Brand Name: DCA VANTAGE PACKED INST USA
• Type of Device: DCA VANTAGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 12515233
• MDR Text Key: 272781842
• Report Number: 3002637618-2021-00054
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 00630414551364
• UDI-Public: 00630414551364
• Combination Product (y/n): N
• PMA/PMN Number: K071466
• 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: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10282969
• Device Catalogue Number: 10282969
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1