MAUDE Adverse Event Report: BECKMAN COULTER DXA 5000; RADIOASSAY, VITAMIN B12

Model Number SER-RBU

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Head Injury (1879)

Event Date 04/22/2021

Event Type  Injury  

Manufacturer Narrative

The failure mode is due to an accidental injury.The fse received immediate treatment to the wound at the accident and emergency department in hospital.No additional medication was prescribed.The fse was monitored on light duties upon his return approximately 60 minutes after the incident.Beckman coulter internal identifier is case-(b)(4).No patient demographic information (age, weight, race or ethnicity) was provided.(b)(6).Device manufacturing date not available.

Event Description

While installing a transport segment of the dxa 5000 system, the fse (field service engineer) sustained an injury to the head which required medical treatment.Per the information provided, the fse installing a dxa track section behind an au rbu, hit his head whilst standing up on the open lid of the rbu.This caused a 10cm gash to his head requiring the cut to be glued in accident and emergency department of mayo hospital.The fse received immediate treatment to the wound at the accident and emergency department in hospital.No additional medication was prescribed.The fse was monitored on light duties upon his return approximately 60 minutes after the incident.

• Brand Name: DXA 5000
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER BIOMEDICAL; sauerbruchstr. 50; munich 81377 ; GM 81377
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 11845882
• MDR Text Key: 251377249
• Report Number: 3006655511-2021-00002
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590720292
• UDI-Public: (01)15099590720292(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K190298
• 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: 05/18/2021

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: SER-RBU
• Device Catalogue Number: B87351
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other