MAUDE Adverse Event Report: HORIBA ABX SAS ABX PENTRA 60C

Catalog Number P60CP001NUA1

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2015

Event Type  malfunction  

Event Description

The customer reported to horiba medical service representative (fsr) that the abx pentra 60c displayed data sensor error and that the customer noted a wire burning smell from the analyzer.A horiba medical fsr was dispatched to determine if the analyzer was malfunctioning.The fsr went on site and found burn marks on the valves and the fan inside the analyzer.Fsr replaced the valve assembly, the pcb main board and the fan.Fsr confirmed the analyzer functioning correctly after the parts replacement.There were no reports of any impact to patient management due to this issue.There were no injuries nor damage to the surrounding lab environment.The parts were returned to horiba medical irvine for analysis by the manufacturer.The analyzer conforms to the ul standards.

• Brand Name: ABX PENTRA 60C
• Type of Device: ABX PENTRA 60C
• Manufacturer (Section D): HORIBA ABX SAS; parc euromedecine; rue du caducee-bp 7290 cedex 4; montpellier, france 34184 ; FR 34184
• MDR Report Key: 5102220
• MDR Text Key: 26738235
• Report Number: 2086725-2015-00005
• 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
• Reporter Occupation: Health Professional
• Report Date: 09/24/2015,09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: P60CP001NUA1
• 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: 09/24/2015
• Distributor Facility Aware Date: 09/09/2015
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/24/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other