MAUDE Adverse Event Report: HORIBA ABX SAS ABX PENTRA 400 ISE ANALYZER; CHEMISTRY ANALYZER

Device Problems Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 10/15/2014

Event Type  malfunction  

Event Description

A horiba medical field service representative (fsr) was dispatched to install a new pentra 400 chemistry analyzer.Upon turning the analyzer on, smoke came out of the power supply from the back of the analyzer.Fsr powered off the unit.Customer was not involved.There is no report of injury or illness in connection with this incident.Management decided to replace the abx pentra 400 chemistry analyzer with another new abx pentra 400 analyzer.The abx pentra 400 analyzer that was malfunctioning was returned to horiba medical in (b)(4) and the analyzer will be returned to horiba (b)(4) (manufacturer) in (b)(4) for evaluation.The new system in was installed with no problems.Fsr verified that the instrument was functioning.

Manufacturer Narrative

The p400 analyzer has been received by horiba medical (b)(4) and will be forwarded to the manufacturer for evaluation.A supplemental mdr will be filed as necessary in accordance with 21 cfr 8103.56 when additional reportable information becomes available.

• Brand Name: ABX PENTRA 400 ISE ANALYZER
• Type of Device: CHEMISTRY ANALYZER
• Manufacturer (Section D): HORIBA ABX SAS; montpellier cedex ; FR
• Manufacturer (Section G): HORIBA ABX, INC.; 34 bunsen dr.; irvine CA 92618 421
• Manufacturer Contact: 34 bunsen dr.; irvine, CA 92618-4210
• MDR Report Key: 4241270
• MDR Text Key: 5012306
• Report Number: 2086725-2014-00008
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2014
• Distributor Facility Aware Date: 10/15/2014
• Device Age: 9 MO
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 11/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1