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); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2018

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/2019.No consequences from this incident have been reported.With this information, a death or serious injury is highly improbable.

Event Description

Siemens healthineers became aware of a data loss on the syngo imaging system.Initially 100 series were reported with notification "archive failed".However, the actual investigation showed that only 30 images out of 2 series were really lost due to a hardware failure.The lost data was clinically relevant; however, no patient rescans were required.The incomplete data was indicated to the user at the time of image loading.There are no injuries attributed to this event.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: 8532089
• MDR Text Key: 142514672
• Report Number: 3002808157-2018-57445
• 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: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 04/19/2019
• 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