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

Model Number DIMENSION VISTA 1500

Device Problem Mechanical Jam (2983)

Patient Problem Laceration(s) (1946)

Event Date 04/20/2022

Event Type  malfunction  

Event Description

The customer contacted siemens and stated that a laboratory technician cut his hand while attempting to remove jammed aliquot plate from in-between elevator and waste chute piston of a dimension vista 1500 instrument.The technician was wearing personal protective equipment (ppe), gloves during the incident.Customer additionally stated the hand cut required multiple bandages.The technician stated that their cut area was not exposed to any other surface prior to bandaging.The technician did not undergo any other medical treatment beyond the initial first aid.There are no known reports of adverse health consequences due to the event.

Manufacturer Narrative

A united states customer contacted a siemens customer care center and reported that a laboratory technician cut his hand while attempting to remove jammed aliquot plate from in-between elevator and waste chute piston of a dimension vista 1500 instrument.The operator obtained a cut that required first aid but did not require further medical (acute or chronic) intervention.The worst-case severity is transient, self-limiting illness or injury (minor) that can be treated with a bandage to stop the bleeding.Long-term illness or infection is not to be expected from this injury.A siemens customer service engineer (cse) was dispatched to the customer's site.During this visit, the cse removed the jammed plate, cleaned elevator, waste chute and pistons without any issues.Then the cse auto aligned the aliquot elevator and restarted the instrument.The instrument is performing according to specifications.No further evaluation of this device is required.

Manufacturer Narrative

Siemens filed the initial mdr 2517506-2022-00121 on 10-may-2022.Corrected data (19-may-2022): the date in section b4 of the initial mdr 2517506-2022-00121 was inadvertently documented as 09-may-2022.The correct date is 10-may-2022.Additional information (18-may-2022): siemens further investigated the issue by reviewing the recorded phone conversation between a siemens specialist and the customer.On the day of the event, the customer requested assistance with removing a jammed aliquot plate from the space between the aliquot elevator and aliquot waste chute piston.While describing this incident with the siemens specialist, the customer reported that herself and her female colleague were unable to locate the jammed aliquot plate.The customer asked if they would be able to go behind the instrument to identify the location of the jammed aliquot plate.The specialist responded that this is possible by going to the back of the instrument and removing the back cover.Subsequently, another colleague helped the customer remove the instrument's back cover and identified the location of the jam.As a result, a customer service engineer (cse) was dispatched to the customer's site to further troubleshoot.Upon cse visit to customer's site, the customer reported to the cse that the male technician cut his right index finger's cuticle on the aliquot elevator while attempting to remove the jammed aliquot plate.As indicated in the initial report, the instrument was operational after the cse visit.Section a3 was updated to reflect the gender of the affected individual.Siemens concluded that the customer's attempt to remove a jammed aliquot plate, at his own discretion, without procedure for removing a jammed aliquot plate in the operator's guide potentially contributed to the event.The instrument is performing according to specifications.No further evaluation of this device is required.

• 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 number: 1226181; brookfield CT 06804
• Manufacturer Contact: christina lam ; 511 benedict avenue; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 14347211
• MDR Text Key: 291316583
• Report Number: 2517506-2022-00121
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• 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: 05/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2017
• 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
• Patient Sex: Male