MAUDE Adverse Event Report: SYSMEX CORPORATION, I SQUARE XN-10; AUTOMATED HEMATOLOGY ANALYZER

Model Number XN-10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Swelling/ Edema (4577)

Event Date 02/05/2021

Event Type  Injury  

Manufacturer Narrative

The service engineer noted power cords and cables dangling loosely onto the floor behind the analyzers where the operator tripped and fell.The rear of the analyzers faces a walkway that is at least 3 feet wide.The se bundled the cords and cables behind the analyzers and off the floor.No systemic product deficiency was identified.

Event Description

While troubleshooting errors on an sa-30 sampler, connected to two xn-10 automated hematology analyzers, the operator tripped on a cable that was attached to the xn-10 analyzers, fell and hit his head.The operator reported to the emergency room for evaluation and received a computerized axial tomography (cat) scan.This event is being reported due to exposure to radiation from the cat scan.There was no report of harm to the patient due to the cat scan.

• Brand Name: XN-10
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• Manufacturer (Section G): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• Manufacturer Contact: nancy gould ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439678
• MDR Report Key: 11331818
• MDR Text Key: 231962505
• Report Number: 1000515253-2021-00002
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XN-10
• Device Catalogue Number: AP795756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2014
• 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 Outcome(s): Other