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

Model Number 10863171

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report due to report code error.No patient rescans were required as the lost studies were obtained prior to august 31, 2016, therefore the data had been already assessed and used for clinical diagnosis prior to the date of the incident ((b)(6) 2016).However, siemens considers this incident an adverse event as the data older than 4 weeks may still have clinical relevance and be used by radiologists for comparison to images received during newer patient examinations.The clinical impact of this inhibited comparison is assessed as low.(b)(6).

Event Description

October 5, 2016 siemens became aware of data loss at the customer's site in (b)(6).The short term storage (sts) attached to the siemens syngo.Plaza system got corrupted due to a handling error during routine maintenance of the hard disc unit (raid) on the sts.During exchange of the hard disc, the configuration was lost; therefore data stored on the raid became no longer available on the sts.However, not all of the data was completely lost due to redundancy in the setup of the syngo.Plaza environment at this site: · a large amount of data lost on the sts has been archived on the long term storage (lts) attached to the syngo.Plaza unit.Thus this data is still available to the user.· a separate subset of the data, which was previously stored on the sts prior to the incident, was found on the scanners where it had been initially created.This data was re-sent to the sts and is available to the user as well.· in total 64 series containing 43 studies were permanently lost.This data was obtained between april and august 2016.Siemens syngo.Plaza system did not contribute to the data loss.There are no injuries and no negative impact has been reported by the customer.

• Brand Name: SYNGO.PLAZA
• 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: 8556967
• MDR Text Key: 161306225
• Report Number: 3002808157-2016-59673
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132532
• 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: 10/05/2016

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: 10863171
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 04/26/2019
• 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