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 03/26/2018

Event Type  malfunction  

Event Description

Customer reports that the device had ruptured while in use.No one was hurt.Arc requested the return of the device.A lab analysis for this type of failure was performed on a similar device.The analysis included an optical microscopy, ct scan, 2d xray and indicated the failure was due to a single component (battery) malfunction.The suspect batteries have not been used in production units since (b)(6) 2015.

• Brand Name: ARC INSTATEMP
• Type of Device: THERMOMETER
• Manufacturer (Section D): ARC DEVICES USA INC.; 1200 north federal highway; suite 207; boca raton FL 33432
• Manufacturer (Section G): ARC DEVICES USA INC.; 1200 north federal highway; suite 207; boca raton FL 33432
• Manufacturer Contact: mary ann greenawalt ; 1200 north federal highway; suite 207; boca raton, FL 33432 ; 5612826074
• MDR Report Key: 7477282
• MDR Text Key: 107455885
• Report Number: 3011197139-2018-00010
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF1-0196
• Device Catalogue Number: CF1-0196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/14/2015
• 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