MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SYNGO IMAGING; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number 10014063

Device Problems Use of Device Problem (1670); Loss of Data (2903)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2016

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report due to report code error.The reported event was evaluated by our factory experts.The syngo imaging system is functioning according to specifications and did not in any way contribute to the data loss.The reported data loss was caused by a hardware problem in the hard disc unit (raid) at the customer site.No consequences for patients have reported.(b)(6).

Event Description

Siemens recently became aware of data loss that had occurred on the syngo imaging system.February 12, 2016, after performing repair actions on the hard disc unit (raid) of the archive that is attached to the syngo imaging product, it was noticed that 6 studies were missing and 6 studies were partially missing.These studies ranged from january 31, 2016 to february 5, 2016.This data loss was discovered by a siemens service engineer who was performing the repair action.The engineer compared the archive status before and after the repair action and discovered data loss.However, the customer allowed to delete studies created prior to february 6, 2016 on affected image partition on the course of the repair actions.The data loss was caused by a hardware error as the raid unit partially crashed.The defective disc was replaced by a (b)(4) service engineer.The lost data was about a week old.It is unknown whether it was used for clinical diagnosis.However, the customer confirmed that data from that period of the time can be deleted.The reported event occurred in (b)(6).

• Brand Name: SYNGO IMAGING
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 8556129
• MDR Text Key: 161306529
• Report Number: 3002808157-2016-33601
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10014063
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/12/2016
• 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
• Patient Outcome(s): Other