MAUDE Adverse Event Report: ARC DEVICES USA INC. ARC INSTATEMP; THERMOMETER

Model Number CF1-0196

Device Problems Nonstandard Device (1420); Product Quality Problem (1506); Device Issue (2379); Battery Problem (2885); Power Problem (3010)

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

Event Date 12/04/2017

Event Type  malfunction  

Event Description

The customer reports that she found the device had ruptured and had come apart.Customer stated that no one was hurt.Arc requested that she return the device.A lab analysis for this type of failure was performed on a similar device.The analysis of the batteries included an optical microscopy, ct scan and 2d x-ray and indicated the failure was due to a single component (battery) malfunction.The suspect batteries have not been used in production units since july 2015.

• Brand Name: ARC INSTATEMP
• Type of Device: THERMOMETER
• Manufacturer (Section D): ARC DEVICES USA INC.; 1200 n. federal highway; suite 207; boca raton FL 33432
• Manufacturer (Section G): ARC DEVICES USA INC; 1200 n. federal highway; suite 207; boca raton FL 33432
• Manufacturer Contact: mary greenawalt ; 1200 n. federal highway; suite 207; boca raton, FL 33432 ; 5612030279
• MDR Report Key: 7108022
• MDR Text Key: 95747326
• Report Number: 3011197139-2017-00117
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CF1-0196
• Device Catalogue Number: CF1-0196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1