MAUDE Adverse Event Report: BECKMAN COULTER AUTOMATE 2500 SAMPLE PROCESSING SYSTEM; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number ODL07037

Device Problem Unintended Collision (1429)

Patient Problem Concussion (2192)

Event Date 03/04/2015

Event Type  Injury  

Event Description

A customer in (b)(6) reported to beckman coulter (bec) that one of their employees had injured their head as a result of raising themselves up from under the keyboard of their automate 2500 sample processing system.The employee had hit their head against the base of the keyboard tray which resulted in a concussion and time off work.The employee was admitted to the emergency room (er) where concussion was diagnosed.The employee was sent directly home after the er visit.It was stated by the customer that the employee self-certified and later was signed off work by a family doctor (gp).As of the (b)(6) 2015 the employee was confirmed to still be off work as a result of the incident.

Manufacturer Narrative

The incident was caused by the employee raising themselves up from under the keyboard of their automate 2500 sample processing system and hitting their head against the base of the keyboard tray.There were no instrument issues in connection with this event.

• Brand Name: AUTOMATE 2500 SAMPLE PROCESSING SYSTEM
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER BIOMEDICAL GMBH; ruppert-mayer-str. 44; muenchen, 8137 9; GM 81379
• Manufacturer Contact: david davis ; 250 s. kraemer blvd. m/s e1.se; brea, CA 92821 ; 7142649714
• MDR Report Key: 4636131
• MDR Text Key: 5591676
• Report Number: 3006655511-2015-00001
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ODL07037
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2015
• Initial Date FDA Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention