MAUDE Adverse Event Report: BECKMAN COULTER WA96 PLUS GENERIC

Model Number B1018-284

Device Problem Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

There was no product malfunction that caused the reported injury.The beckman field service engineer (fse) was conducting a system test when the injury was sustained.Fse¿s shoulder popped while extending his arm to push the button to open the access hatch to the walkaway instrument.The fse indicated he was sitting down in a chair working with his lap top when the test asked for the button to be pressed.The button was located on the top of the instrument and when extending their arm while sitting, this created an awkward posture and an overextension of the shoulder, causing a sprain.The fse visited a physician for the injury and was put on work restriction.He had surgery on (b)(6) 2019 and he has since recovered and back to work.No patient demographic information provided.There was no unique device identifier labeling when the affected instrument was manufactured and installed.The instrument is a class ii device that was manufactured on march 10, 2016 prior to the fda¿s mandated deadline of september 24, 2016.Beckman coulter internal identifier is (b)(4).

Event Description

While onsite on (b)(6) 2018 conducting a repair on walkaway (wa) 96 plus, serial number (b)(4), the beckman coulter field service engineer (fse) injured his shoulder.

• Brand Name: WA96 PLUS GENERIC
• Type of Device: WA96 PLUS GENERIC
• Manufacturer (Section D): BECKMAN COULTER; 2040 enterprise blvd; west sacramento CA 95691
• Manufacturer (Section G): BECKMAN COULTER; 2040 enterprise blvd; west sacramento CA 95691
• Manufacturer Contact: hellen fox ; 1584 enterprise blvd; west sacramento, CA 95691 ; 9163742313
• MDR Report Key: 8876535
• MDR Text Key: 153801100
• Report Number: 2919016-2019-01001
• Device Sequence Number: 1
• Product Code: LRG
• UDI-Device Identifier: 15099590658687
• UDI-Public: (01)15099590658687(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: B1018-284
• Device Catalogue Number: B1018-284
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/29/2018
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2016
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other