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

Model Number CF1-0196

Device Problem Low Sensing Threshold (2575)

Patient Problems Fever (1858); Patient Problem/Medical Problem (2688)

Event Date 06/13/2017

Event Type  malfunction  

Event Description

The customer reported their thermometer was giving false negative readings.The device was reported as reading 4-5 degrees lower than the child's rectal temperature.The customer reports she took her child to the hospital.There were no reported complications from this incident.Arc devices has requested that the product be returned to our company for lab analysis.

• Brand Name: ARC INSTATEMP INFRARED THERMOMETER
• Type of Device: INFRARED 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: 6708566
• MDR Text Key: 79965722
• Report Number: 3011197139-2017-00101
• 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: 06/23/2017

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: 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
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 9 MO
• Patient Weight: 9