MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500

Model Number DIMENSION VISTA 1500

Device Problem Device Handling Problem (3265)

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

Event Date 10/18/2019

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 alternating current (ac) power distribution board was damaged and replaced the damaged ac power distribution board.The cse also removed and discarded the reagents, quality controls (qcs), and calibrators.Then, the cse ran a full quick check test, loaded new reagents, and ran qcs and calibrations, which recovered acceptably.Siemens further investigated the issue.Siemens determined that the customer followed the procedure to loosen the cap of the sample probe cleaner bottle to prevent back pressure and allow the fluid to properly fill the lower bowl.However, the cap was too loose and fell off.Having the cap off would not have caused the splash.However, since the customer placed a fan in front of the instrument (with the instrument doors open), sample probe cleaner fluid that was on the outside of the bottle splashed onto the electronics in the instrument, causing a short.A use error contributed to this event.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

The customer reported they inadvertently spilled sample probe cleaner onto the motherboard of the dimension vista 1500 instrument, causing it to shut down, when they attempted to replace the sample probe cleaner.During this time, the customer reported that they observed sparks and a small fire, which diminished.The customer contacted maintenance to unplug the instrument.There was no delay to patient testing because the customer ran samples on an alternate instrument in the laboratory.There are no known reports of adverse health consequences due this event.

• Brand Name: DIMENSION VISTA 1500
• Type of Device: DIMENSION VISTA 1500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration # : 1226181; brookfield CT 06804
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 9314508
• MDR Text Key: 191027319
• Report Number: 2517506-2019-00428
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION VISTA 1500
• Device Catalogue Number: 10444801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1