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 No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2017

Event Type  malfunction  

Event Description

Customer reports that she heard a "pop" and found the device had popped open and that one battery ruptured in the device and the other battery (two batteries total) was expelled across the room.The device was sitting on a shelf and unattended.No one was hurt.The device was returned to arc.A lab analysis of this type of unit 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 ; 5612826074
• MDR Report Key: 6754158
• MDR Text Key: 81437835
• Report Number: 3011197139-2017-00102
• 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: 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: 06/23/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2015
• 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