MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500

Model Number	DIMENSION VISTA 500
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens regional support center (rsc) and reported aliquot positioner errors and stated that the aliquot probe was failing when aligning the modules.The rsc assisted the customer with replacing the aliquot probe.While on the phone with rsc performing the aliquot probe alignment procedure, the customer reported she leaned into the dimension vista 500 instrument and the metal probe guard hit her prescription glasses and then hit her face.The metal guard on the aliquot probe may have had biohazardous material on it as it is used for patient sampling.The rsc informed the customer that best safety practice is to observe visually from a safe distance when the instrument is moving.The customer, assisted by rsc was unable to autoalign the aliquot probe and the rsc dispatched a siemens customer service engineer (cse) to address the issue.A cse called the customer site and worked with another operator to align the aliquot probe on the dimension vista 500 instrument.The operator cleaned different points where the probe failed, adjusted the probe several times and successfully realigned the probe.The cause of the event is use error.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that she received a bruise and small cut on her face when she leaned into the dimension vista 500 instrument while running a diagnostic test to align the aliquot probe.The customer had a physical examination in the emergency room on (b)(6) 2021 and she informed siemens that the cut she obtained was a superficial abrasion that did not require medical treatment.There are no known reports of adverse health consequences due to the injury the customer sustained.

• Brand Name: DIMENSION VISTA 500
• Common Device Name: DIMENSION VISTA 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gcb drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; registration number: 1226181; brookfield CT 06804
• Manufacturer Contact: amy wolfe ; 511 benedict avenue; tarrytown, NY 10591
• MDR Report Key: 13002500
• Report Number: 2517506-2021-00339
• Device Sequence Number: 14526058
• Product Code: JJE
• UDI-Device Identifier: 00630414593517
• UDI-Public: 00630414593517
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2021

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
• Operator of Device: Health Professional
• Device Model Number: DIMENSION VISTA 500
• Device Catalogue Number: 10284473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown