MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. LANTIS SYSTEM

Model Number 05835991

Device Problems Computer Software Problem (1112); Loss of Data (2903); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2014

Event Type  malfunction  

Event Description

Te customer informed siemens on (b)(6) 2014 that they had confirmed a set of field parameters and attempted to open that set for transcription (editing), then lantis crashed.The customer restarted lantis, opened the same patient and found that all of the previously defined parameters were not just lost but were replaced by some random created values.Lantis produced two error messages after recognizing the corrupted set of data.The customer is concerned that if only one parameter had been changed instead of losing the full set, it is possible that a single parameter overwrite would not be recognized.There is no report of mistreatment or injury to a patient.This reported issue occurred in (b)(6).

Manufacturer Narrative

Siemens became aware of the reported occurrence on (b)(6) 2014.This mdr is being mailed on (b)(4) 2014.The investigation is on-going and a supplemental report will be submitted upon completion.

• Brand Name: LANTIS SYSTEM
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA
• Manufacturer Contact: marlynne galloway ; 51 valley stream pkwy, ms-d02; malvern, PA 19355 ; 6102195361
• MDR Report Key: 4047698
• MDR Text Key: 16541776
• Report Number: 2910081-2014-05831
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K972275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 05835991
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1