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

Model Number 10014063

Device Problems Electrical /Electronic Property Problem (1198); Use of Device Problem (1670); Loss of Data (2903)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2016

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report due to report code error.(b)(6).

Event Description

It was reported that a server room at the customer's facility had a power outage in october 2016, which resulted in the failure of the raid (hard disk unit) attached to the siemens syngo imaging system.A previous power outage that occurred earlier (september 2016) had already deactivated the raid mirroring function.Therefore, the data was not protected by any back-up option.After the assessment was conducted, it was determined that 15 potentially clinically relevant studies dated between october 13th and 15th were lost.This data will not be available for diagnosis if required by physician.The syngo imaging system did not contribute to the reported data loss.No consequences have been reported from this customer.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: 8556984
• MDR Text Key: 161306612
• Report Number: 3002808157-2016-58408
• 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: 10/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10014063
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/16/2016
• 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