MAUDE Adverse Event Report: EPOCAL INC. EPOC BLOOD ANALYSIS SYSTEM

Catalog Number HR00020000

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2015

Event Type  malfunction  

Manufacturer Narrative

This is the first event reported of its kind in 9 years of operation.In (b)(6) 2014, a business decision was made for unrelated reasons to switch to different supplier.As of this date, the device has not been returned to epocal for investigation.Globtek has been made aware about this event.If the device is returned, a full investigation will be performed and a f/u report will be submitted.

Event Description

It was reported in case number (b)(4) that "the charger used along with epoc reader is broken, the pins have become detached and someone has received an electric shock.It was later confirmed that the plastic casing on the 3 pin plug appears to have come detached and the user may have touched the metal contacts accidentally and received the small shock.They are fine and nothing further has been done".The epoc reader (catalog number hr-1002-00-00) functions with a power supply (supplied by mfg globtek inc.) which utilizes a variety of input connectors (depending on the region they are to be used in).This event occurred in (b)(6) with (b)(6) input connector (epoc catalog number ar-0006-00-00), mfr globtek part number (b)(4)).A picture provided by the initial reporter shows that the input connector separated into two parts thereby exposing the bac of the prongs which are inserted into the wall outlet.

• Brand Name: EPOC BLOOD ANALYSIS SYSTEM
• Type of Device: EPOC BLOOD ANALYSIS SYSTEM
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa ; CA
• Manufacturer (Section G): EPOCAL INC.; 2060 walkley road; ottawa ; CA
• Manufacturer Contact: james badarpura ; 2060 walkley road; ottawa ; CA ; 6883982
• MDR Report Key: 5396699
• MDR Text Key: 37243629
• Report Number: 3004959793-2015-00001
• Device Sequence Number: 1
• Product Code: CGL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K113726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HR00020000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1