MAUDE Adverse Event Report: BECKMAN COULTER 5K STORAGE, POWER EXPRESS; RADIOASSAY, VITAMIN B12

Model Number 5K STORAGE, POWER EXPRESS

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Head Injury (1879); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/13/2021

Event Type  Injury  

Manufacturer Narrative

The beckman coulter field service engineer (fse) was evaluating the 5k stockyard system.The fse attempted to get off the floor and accidentally grabbed the handle of the 2nd level and was injured on his forehead while getting up from the floor.The cause of the injury was due to the fse grabbing the handle of the instrument.The extent and treatment of the injury is currently unknown.Beckman coulter internal identifier is (b)(4).No patient demographic information (age, weight, race or ethnicity) was provided.Udi not available due to no serial number provided.Device manufacture date information not available due to no serial number provided.

Event Description

While servicing the 5k storage power express, the field service engineer (fse) attempted to get off the floor and accidentally grabbed the handle of the 2nd level and hit himself on the forehead.The extent of the injury and if any treatment was received is currently unknown.

Manufacturer Narrative

Upon follow up, the fse stated he had a small cut and was bleeding on his forehead due to the injury.Fse used the first aid treatment to stop the bleeding.No stitches were required.Fse went to the medical er (emergency room) and received a tetanus shot.No medication was prescribed.Fse did not miss any work due to the injury.Beckman coulter internal identifier is (b)(4).A2, a3, a4, a5: no patient demographic information (age, weight, race or ethnicity) was provided.D4: udi not available.E1: phone number not provided.H4: device manufacture date information not available.

Event Description

The field service engineer (fse) attempted to get off the floor and accidentally grabbed the handle of the 2nd level and hit himself on the forehead.Upon follow up, the fse stated he had a small cut and was bleeding on his forehead due to the injury.Fse used the first aid treatment to stop the bleeding.No stitches were required.Fse went to the medical er (emergency room) and received a tetanus shot.No medication was prescribed.Fse did not miss any work due to the injury.

• Brand Name: 5K STORAGE, POWER EXPRESS
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 11325720
• MDR Text Key: 232058685
• Report Number: 2050012-2021-00006
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• PMA/PMN Number: K140496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

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: Other
• Device Model Number: 5K STORAGE, POWER EXPRESS
• Device Catalogue Number: B36361
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other