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 09/03/2014

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" and that the customer noticed cooling unit power cord is burnt at the entrance/connector to the cooling unit.Customer powered off the unit and called horiba for service.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 the power entry module and power plug had melted/burnt at the power input connection to the compressor.The fsr replaced the power cord and the compressor power input module, and verified that the instrument settings were correct and that the analyzer was functioning.The damaged power cable connectors were returned to horiba for examination.

Manufacturer Narrative

The part has been received by horiba and forwarded to mfr for eval.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable info becomes available.

• 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: 4135192
• MDR Text Key: 4797125
• Report Number: 2086725-2014-00007
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• 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: 09/24/2014
• Distributor Facility Aware Date: 09/03/2014
• Device Age: 6 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1