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

Model Number DYNAMIC INLET PLC (BULK READY) POWER EXPRESS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Abrasion (1689)

Event Date 05/30/2023

Event Type  Injury  

Manufacturer Narrative

Beckman coulter field service engineer (fse) was dispatched to the customer site and evaluated the power express.Upon arrival, fse noted that the customer had already placed the cover back on the inlet.Fse checked the inlet cover and verified it was secure.Fse unlocked one latch and observed that the cover fell forward.Fse opened the inlet cover and noted that the spring latch might have come loose from metal catch over time due to vibration from the unit.Fse adjusted the left and right metal catch to better secure spring latches on the front cover.Re-installed the front cover.In addition, tightened outlet units' front covers as per customer¿s request.For verification, fse unlocked one latch and verified that the cover does not fall forward.Closed cover and performed a stress test.Pulled cover with force to ensure cover does not come loose without unlocking latches.No hardware parts were replaced.No further issues were reported.The beckman coulter internal identifier is case: (b)(4).

Event Description

Beckman coulter field service engineer (fse) reported that the customer was injured due to the power express inlet module front bottom cover came loose and fell forward.The customer was injured on her right leg.The customer had a skin cut on a right leg and left foot.The customer was taken to the er for treatment.An x-ray was taken and confirmed that there was no fractured bone.The customer was on a medical leave for 2 (two) days due to the injury.It is unknown if the customer was wearing protective equipment at the time of the incident.

• Brand Name: POWER EXPRESS
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 17173375
• MDR Text Key: 317629865
• Report Number: 2050012-2023-00145
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590681555
• UDI-Public: (01)15099590681555(11)170601
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K140496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2023

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: Health Professional
• Device Model Number: DYNAMIC INLET PLC (BULK READY) POWER EXPRESS
• Device Catalogue Number: B90918
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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