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

Model Number CF1-0196

Device Problems Nonstandard Device (1420); Product Quality Problem (1506); Battery Problem (2885); Manufacturing, Packaging or Shipping Problem (2975); Power Problem (3010)

Patient Problem Missing Value Reason (3192)

Event Date 04/05/2017

Event Type  malfunction  

Event Description

The consumer reported that the device was unattended and on a shelf near daughter's crib.She reported she found the device exploded with debris on the floor and ash inside the crib.Arc requested that the device be returned.The device has not been returned.This type of occurrence had not previously been reported prior to this incident.Since that time four more incidents were reported and a lab analysis was performed on two of those devices.The analysis of the batteries included an optical microscopy, ct scan and 2d x-ray which indicated that the failure was due to a single component (battery) malfunction.The suspect batteries have not been used in production since 17 july 2015.

• Brand Name: ARC INSTATEMP
• Type of Device: THERMOMETER
• Manufacturer (Section D): ARC DEVICES USA INC.; 1200 n. federal hwy ste 207; boca raton FL 33432
• Manufacturer (Section G): ARC DEVICES USA INC.; 1200 n. federal hwy ste 207; boca raton FL 33432
• Manufacturer Contact: mary greenawalt ; 1200 n. federal hwy ste 207; boca raton, FL 33432 ; 5612030279
• MDR Report Key: 6754570
• MDR Text Key: 81488958
• Report Number: 3011197139-2017-00106
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• 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: 04/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/10/2015
• 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