MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number REMFG TN,DXH800 REMANUFACTRED WITH FLOOR STAND

Device Problem Electrical Shorting (2926)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2021

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was at the customer site and confirmed what was reported.The fse discovered that the issue was due to waste overflow from the waste container which came in contact with power cord that had momentarily fallen to the ground.The fse observed that the customer was using a direct waste container with no sensor to indicate the waste level.The fse fitted the waste container with internal waste tubing and a waste sensor.The event was assessed by the product compliance engineering team for evaluation.Based upon further review the following was concluded: from the event details provided and additional information, it can be concluded that the electrical safety hazard was mitigated by the design, and that the electrical short was resolved by the circuit breaker tripping on the ups.There was no hazard presented as a result of this occurrence.Safety ratings: class: (b)(4): electrical laboratory equipment certified to us standards.Class: (b)(4): electrical laboratory equipment.Hematology analyzer, models unicel dxh 600, dxh 690t, dxh 800 and dxh 900.Electrical.Ratings noted below: applicable requirements: can/csa-c22.2 no.(b)(4):15 safety requirements for electrical equipment for measurement, control, and laboratory use, part 2: particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes can/csa-c22.2 no.(b)(4):15 safety requirements for electrical equipment for measurement, control, and laboratory use, part 2: particular requirements for in vitro diagnostic (ivd) medical equipment can/csa-c22.2 no.(b)(4) safety requirements for electrical equipment for measurement, control, and laboratory use, part 1: general requirements (b)(4) (2nd edition) safety requirements for electrical equipment for measurement, control, and laboratory use, part 2: particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes (b)(4) (2nd edition) safety requirements for electrical equipment for measurement, control, and laboratory use, part 2: particular requirements for in vitro diagnostic (ivd) medical equipment (b)(4) (3rd edition) safety requirements for electrical equipment for measurement, control, and laboratory use, part 1: general requirements bec internal identifier: (b)(4).

Event Description

The customer reported the power cord on their unicel dxh 800 hematology instrument had short circuit.Smoke and sparks were observed by the customer at the time of the event.The short resulted in thermal damage of the power cord.The spark was isolated and did not require the use of a fire extinguisher.There was no visible fire and the fire department was not called.Medical intervention was not required due to this event.There was no impact to patient results, the instrument was powered off when the incident occurred.

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12465752
• MDR Text Key: 271268315
• Report Number: 1061932-2021-00109
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590687922
• UDI-Public: (01)15099590687922(11)180504
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REMFG TN,DXH800 REMANUFACTRED WITH FLOOR STAND
• Device Catalogue Number: B63322
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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