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 Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)

Event Date 06/01/2017

Event Type  malfunction  

Event Description

The consumer stated the device was sitting on a coffee table (unattended) and her husband heard a "pop" and saw that the unit had come apart.The customer stated there was black dust on her coffee table.No one was hurt.Arc requested that the unit be returned for investigation.The unit was returned to arc.A lab analysis of this type of failure was performed.There was no issue with the design of the device.The analysis of the battery 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 since (b)(6) 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: 6754175
• MDR Text Key: 81479096
• Report Number: 3011197139-2017-00104
• 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: Other
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2015
• 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