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

Model Number CF!-0196

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2017

Event Type  malfunction  

Event Description

The consumer stated that the device was found in the consumer's medicine cabinet with a ruptured battery.No one was harmed.Arc requested that the unit be returned for investigation.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.Report, attached.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: 6884569
• MDR Text Key: 89309080
• Report Number: 3011197139-2017-00107
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: CF!-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
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1