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

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 05/21/2018

Event Type  malfunction  

Event Description

Customer reports that the thermometer was found in a ruptured state.No one was hurt.Arc requested the return of the device.A lab analysis for this type of failure was performed on a similar device.The analysis included an optical microscopy, ct scan, 2d x-ray, and indicated the failure was due to a single component (battery) malfunction.The suspect batteries have not been used in production units since july 2015.

• Brand Name: ARC INSTATEMP
• Type of Device: THERMOMETER
• Manufacturer (Section D): ARC DEVICES USA INC.; 1200 n. federal highway; ste 207; boca raton 33432
• Manufacturer (Section G): ARC DEVICES USA INC.; 1200 n. federal highway; ste 207; boca raton 33432
• Manufacturer Contact: mary greenawalt ; 1200 n. federal highway; ste 207; boca raton 33432 ; 5612826074
• MDR Report Key: 7575376
• MDR Text Key: 110588731
• Report Number: 3011197139-2018-00013
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• PMA/PMN Number: K152095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• 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: 05/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2015
• 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