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

Model Number 10091637

Device Problems Use of Device Problem (1670); Loss of Data (2903); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report due to report code error.An investigation was performed with the factory, service, and the site.The results were that of the 80 studies identified as not being found in the sd product: a few (5) of the studies are available in the archive and can be loaded into the sd system if desired, a few (3) of the studies were received into the sd system and then were deleted by a user workstation, and the majority (72) of the studies have no evidence that they were ever received by the sd system (primarily jun/jul 2011).This result is based upon an investigation of all available information which still exists.The clinical relevance is that the missing studies are not available to the user for comparison with other studies.The syngo dynamics product has not caused or contributed to the loss of data, there is no reasonably foreseeable path to occurrence of patient harm based upon the product.This is considered to be an unrecoverable loss of clinically-relevant data not caused, or contributed to, by the sd product.(b)(6).

Event Description

It was identified at customer's site that 80 studies presumed to be missing from the syngo dynamics (sd) product dating from june 2011 through april 2014.There was no injury associated with this issue.No data mix-up or loss occurred which would result in the need for a patient rescan.The reported event occurred in (b)(6).

• Brand Name: SYNGO DYNAMICS
• 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: 8560506
• MDR Text Key: 161589528
• Report Number: 3002808157-2017-99070
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102150
• 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: 10/04/2017

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: 10091637
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 04/29/2019
• 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