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

Catalog Number ODL07037

Device Problems Unintended Collision (1429); Human-Device Interface Problem (2949)

Patient Problem Laceration(s) (1946)

Event Date 09/09/2014

Event Type  Injury  

Event Description

A beckman coulter (bec) field service engineer (fse) stood up from beneath the pc holder housing and struck his head on the edge of the automate keyboard mount while performing routine maintenance for the automate 2500 sample processing system.The fse received a cut along the top of the head, and received four (4) staples which were administered by a local hospital.The fse has had no further issues related to the event.The system was not in operation when the event occurred.The event occurred at a hospital in the (b)(6).

Manufacturer Narrative

The system was not in operation when the incident occurred, and 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: dung nguyen ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149614941
• MDR Report Key: 4153451
• MDR Text Key: 4932845
• Report Number: 3006655511-2014-00001
• 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,Company Representative
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 09/09/2014

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: Service Personnel
• Device Catalogue Number: ODL07037
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/09/2014
• Initial Date FDA Received: 10/08/2014
• 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