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

Model Number 10592457

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 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/2019.Sts is intended only for temporary storage of patient data until it is transferred to lts (long term storage).The syngo.Plaza is working as designed and according to the specifications; the reported data loss was unrelated to the syngo.Plaza product.The syngo.Plaza product did not contribute to the partial data loss at the concerned site.(b)(6).

Event Description

Siemens became aware of an issue with disk 5, where the sts (short term storage) is located, on the syngo.Plaza unit.During normal operation disk 5 was marked as "unallocated', resulting in the syngo.Plaza being unable to read images/patient data.The reported issue is a hardware issue.Possibility to recover the disk 5 is currently being assessed by siemens technical experts.The amount of potentially lost data is currently unknown.There are no injuries attributed to the reported event.The reported event occurred in (b)(6).

• Brand Name: SYNGO.PLAZA
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 16; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 16; erlangen, 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 8541101
• MDR Text Key: 142799200
• Report Number: 3002808157-2019-61252
• 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: 12/13/2018

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: 10592457
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 04/23/2019
• 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