MAUDE Adverse Event Report: BECKMAN COULTER WA96 PLUS GENERIC

Model Number	B1018-284
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/29/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: WA96 PLUS GENERIC
• Manufacturer (Section D): BECKMAN COULTER; 2040 enterprise blvd; west sacramento CA 95691
• MDR Report Key: 8876535
• Report Number: 2919016-2019-01001
• Device Sequence Number: 2754817
• Product Code: LRG
• UDI-Device Identifier: 15099590658687
• UDI-Public: (01)15099590658687(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K911400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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
• Operator of Device: Other
• Device Model Number: B1018-284
• Device Catalogue Number: B1018-284
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/29/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 01/27/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other