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 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) to troubleshoot an error message ("reagent server 1 cannot find home") that was produced by the dimension vista 1500 instrument.As per siemens instructions, the customer removed the server access door and removed the jammed flex.The customer was able to home all modules, initialize sever 1 without error, and reset the instrument.Then, the customer reported that they obtained a "flex failed to trash" error and the customer entered diagnostics mode on the instrument.The customer reported that an operator sustained an injury to the hand when he attempted to clean the waste chute and remove the jammed flex.He was injured by the bottom of the flex waste chute.Another operator attempted to troubleshoot this issue with the ccc specialist; the operator pushed the flex back onto the sever, homed, and initialized the server/storage ring.When the operator tried to send the flex to trash, the flex was stuck at the top of the chute and the operator was not able to remove the flex.A siemens customer service engineer (cse) was dispatched to the customer's site.After inspecting the instrument, the cse removed the climate control module (ccm) and waste chute to clear the jam.Then, the cse cleaned the waste chute, reassembled the instrument, and verified that flexes went to trash.Siemens further investigated the issue.Siemens determined that the customer used a tubing to clear the jam, but the customer was too close to the waste chute when he cut his hand.Tubing should be used to clear jammed flexes and should be the only object near the waste chute.Furthermore, by design, the waste chute has round edges to prevent injuries.The operator's method in dislodging the jam contributed to the event.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

An operator of a dimension vista 1500 sustained an injury to the hand while trying to dislodge a jammed flex.The operator was wiping out the flex waste chute from the bottom when he was injured.He visited the emergency room (er) for medical attention, where he received 3 to 4 stitches.The customer did not provide additional information regarding this operator due to confidential regulations.There are no known reports of adverse health consequences due to 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: 9370225
• MDR Text Key: 191030022
• Report Number: 2517506-2019-00443
• 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: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• 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: 10/31/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/21/2017
• 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