MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DCA VANTAGE

Model Number 10282969

Device Problem Data Problem (3196)

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

Event Date 02/15/2022

Event Type  malfunction  

Manufacturer Narrative

Siemens has shown due diligence in requesting further information and instrument log files from the customer however the customer has not responded and therefore no further investigation can be performed.The customer has not had any additional issues since this event.The cause of this event is unknown.

Event Description

The customer reported that they had one incident where the results of one patient were reported to a different patient's id.There has been no report of injury due to this event.

• Brand Name: DCA VANTAGE
• Type of Device: DCA VANTAGE
• 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 ; 2 edgewater drive; norwood, MA 02062 ; 6107052212
• MDR Report Key: 14219086
• MDR Text Key: 290164600
• Report Number: 3002637618-2022-00028
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 00630414551364
• UDI-Public: 00630414551364
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071466
• 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
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1