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 Not Applicable (3189)

Event Date 12/23/2014

Event Type  malfunction  

Event Description

Customer reported to horiba medical (horiba) that the compressor connected to their abx pentra 400 chemistry analyzer is reporting compressor "errors" with blown fuses.There was no injury or illness in connection with this incident.A horiba medical field service representative (fsr) was dispatched to determine if the instrument was malfunctioning.The fsr confirmed that the cooling unit power receptacle melted on the inside where fuse burned out with contacts missing on the other side of fuse box.The fsr replaced the power receptacle and fuses, and verified that the instrument settings were correct and that the analyzer was functioning.The damaged power cable connectors will be returned to horiba irvine for evaluation.

• Brand Name: ABX PENTRA 400 ISE ANALYZER
• Type of Device: CHEMISTRY ANALYZER
• Manufacturer (Section D): HORIBA ABX SAS; montpellier, cedex 4 ; 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: 4444673
• MDR Text Key: 16084568
• Report Number: 2086725-2015-00001
• Device Sequence Number: 1
• Product Code: JJE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 01/21/2015
• Distributor Facility Aware Date: 12/23/2014
• Device Age: 3 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 01/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1