MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BS-2000M CHEMISTRY ANALYZER

Model Number BA2KA-CTO-S01

Device Problems Collapse (1099); Mechanical Problem (1384); Structural Problem (2506)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

It is confirmed that the reported issue was caused by a failure of the cover's air spring.

Event Description

It was reported that when the operator of a bs-2000m chemistry analyzer picked up the front protective cover and loaded the reagents, then the protective cover suddenly fell and hit the operator's arm, leaving a superficial cut on the arm.No serious injury was reported.

• Brand Name: BS-2000M CHEMISTRY ANALYZER
• Type of Device: BS-2000M
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; 1203 nanhuan avenue; guangming district; shenzhen, 51810 6; CH 518106
• Manufacturer Contact: serena chen ; 1203 nanhuan avenue; guangming district; shenzhen, guangdong 51810-6 ; CH 518106
• MDR Report Key: 9271865
• MDR Text Key: 200695741
• Report Number: 3009156722-2019-00006
• Device Sequence Number: 1
• Product Code: JGS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K160370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BA2KA-CTO-S01
• Device Catalogue Number: BA2KA-CTO-S01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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