MAUDE Adverse Event Report: BECKMAN COULTER AU5800 CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number AU5800-10, CHEMISTRY ANALYZER AU5800

Device Problem Smoking (1585)

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

Event Date 06/20/2021

Event Type  malfunction  

Manufacturer Narrative

A beckman coulter field service engineer (fse) was not dispatched to the customer site.The fire department was called to customer's site due to smoke emanating from ups room.When fire department arrived, an infra-red (ir) scanner was used to verify that the ups was not producing any flames or smoke.There were no visible flames observed.No extinguishing material was used.Customer had local biomed arrive onsite.Au5880 analyser did not contribute to the incident.Ups system replaced by local biomed to resolve the issue.No further issues were reported.Beckman coulter internal identifier is (b)(4).Information not applicable as no patient involvement.

Event Description

It was reported the customer¿s uninterrupted power supply (ups) possibly caught fire.This ups unit is externally connected to the au5800 clinical chemistry instrument.There was no report of an injury or harm to patients, users or other persons attributable to the device in this event.The fire department was called to customer's site due to smoke emanating from ups room.There was no customer injury or exposure to flames or smoke.

• Brand Name: AU5800 CLINICAL CHEMISTRY ANALYZER
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER MISHIMA K.K.; 454-32 higashino; nagaizumi-cho sunto-gun; schizuoka JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12123182
• MDR Text Key: 260106221
• Report Number: 9612296-2021-00243
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 14987666541296
• UDI-Public: (01)14987666541296(11)150701
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU5800-10, CHEMISTRY ANALYZER AU5800
• Device Catalogue Number: B23279
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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