MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL 200

Model Number DIMENSION EXL 200

Device Problem Device Handling Problem (3265)

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

Event Date 07/19/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center after spilling water on the uninterruptible power supply (ups) unit.Siemens advised the customer to disconnect the ups unit and clean the spill.When preparing the ups unit back for shipment, the customer reported that the ups unit shorted and smoke emitted from the ups unit.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse inspected the instrument, replaced the ups unit, and ran a system check test, resulting acceptably.Then, the customer ran quality controls, resulting within expected ranges.Siemens further investigated the event and determined that the cause of the event was due to a use error.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

The customer reported that the uninterruptable power supply (ups) unit on a dimension exl 200 instrument stopped functioning after water was spilled on the ups unit.When preparing the ups unit for shipment for repair, the customer observed that smoke emitted from the ups unit.There are no reports of injury or damage to property due to the smoke that emitted from the ups unit.

Manufacturer Narrative

Siemens filed the initial mdr on (b)(6) 2018.Corrected information(b)(6) 2018:the initial mdr indicated that the customer observed smoke emitting from the uninterruptable power supply (ups) unit on a dimension exl 200 instrument when preparing the ups unit for shipment on (b)(6) 2018.The customer did not observe smoke emitting from the ups unit on (b)(6) 2018.On (b)(6) 2018, the customer spilled water on the instrument, shut down the instrument, and disconnected the ups unit.On (b)(6) 2018 a siemens customer service engineer (cse) observed smoke emitting from the instrument when preparing the ups unit for repair.The date in section b3 was updated to reflect the corrected information.The date in section g4 cannot be updated to (b)(6) 2018since it was required for the supplemental mdr.Section b5 was updated to reflect the corrected information.Additional information (b)(6) 2018 there were no reports of delay in patient testing due to this event.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

On (b)(6) 2018 , the customer spilled water on the instrument, shut down the instrument, and disconnected the ups unit.On (b)(6) 2018 , a siemens customer service engineer (cse) observed smoke emitting from the instrument when preparing the ups unit for repair.There were no reports of delay in patient testing due to this event.

• Brand Name: DIMENSION EXL 200
• Type of Device: DIMENSION EXL 200
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7770177
• MDR Text Key: 116709329
• Report Number: 2517506-2018-00447
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414593579
• UDI-Public: 00630414593579
• Combination Product (y/n): N
• PMA/PMN Number: K073604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION EXL 200
• Device Catalogue Number: 10636929
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1