MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. SYNGO LAB DATA MANAGER

Model Number SYNGO LAB DATA MANAGER

Device Problem Mechanical Problem (1384)

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

Event Date 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse determined that the syngo server overheated, generating the smoke to be emitted.The cse ordered another sldm and an uninterrupted power supply (ups).

Event Description

The customer reported that smoke emitted from a syngo lab data manager system (sldm).The customer stated that smoke emitted from the back and front of the computer.The sldm was disconnected from power and a fire extinguisher was used to put out the source of smoke.The customer indicated that there was no delay in testing patient samples.There are no known reports of adverse health consequences due to the smoke that emitted from the syngo lab data manager system.

Manufacturer Narrative

Siemens filed initial mdr 2517506-2019-00297 on 24-jul-2019 and the first supplemental mdr on (b)(6) 2019.Additional information (04-sep-2019): the customer discarded the malfunctioned syngo lab data manager system (sldm).The potential cause of the smoke was not identified because the sldm was discarded by the customer before the cause could be assessed.The instrument is performing according to specifications.No further evaluation of this device is required.

Manufacturer Narrative

Siemens filed initial mdr 2517506-2019-00297 on (b)(6) 2019.Additional information (b)(6) 2019): a siemens customer service engineer (cse) was dispatched to the customer's site and replace the syngo lab data manager system (sldm) and an uninterrupted power supply (ups).The cse also connected and registered the sldm via siemens remote service (srs).The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: SYNGO LAB DATA MANAGER
• Type of Device: SYNGO LAB DATA MANAGER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 8824226
• MDR Text Key: 175413376
• Report Number: 2517506-2019-00297
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2019

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: SYNGO LAB DATA MANAGER
• Device Catalogue Number: 10638933
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 07/25/2019; 09/04/2019
• Supplement Dates FDA Received: 08/19/2019; 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1