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

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 10/16/2017

Event Type  malfunction  

Event Description

Customer reports that he reached into his bag to grab the thermometer and found that the battery had ruptured.No one was hurt.Arc requested the customer return the product.A lab analysis for this type of failure was performed on 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.Report, attached.The suspect batteries have not been used in production units since july 2015.

• Brand Name: ARC INSTATEMP
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): ARC DEVICES USA, INC.; 1200 n. federal highway; ste 207; boca raton FL 33432
• Manufacturer (Section G): ARC DEVICES USA INC.; 1200 n. federal highway; ste 207; boca raton FL 33432
• Manufacturer Contact: mary greenawalt ; 1200 n. federal highway; ste 207; boca raton, FL 33432 ; 5612826074
• MDR Report Key: 7021224
• MDR Text Key: 92660354
• Report Number: 3011197139-2017-00112
• 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: Emergency Medical Technician
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Emergency Medical Technician
• 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: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2015
• 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