MAUDE Adverse Event Report: ARC DEVICES USA INC ARC INSTATEMP NON-TOUCH THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Device Problems Burst Container or Vessel (1074); Smoking (1585); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2018

Event Type  malfunction  

Event Description

During patient assessment in the pacu the physician picked up a handheld infrared "touchless" thermometer to scan the patient's temperature.While holding the thermometer in her hand the thermometer burst apart in the physician's palm and emitted a large spark and smoke.The physician tossed the thermometer away from the patient and bed area.The thermometer was retrieved and sent to biomedical for evaluation along with other thermometers of the same make for inspection.It was noted that the electronic thermometer had a one time use embedded battery which could not be replaced or exchanged.Biomedical performed a maude database search on this model thermometer and noted frequent and similar events in which the battery failed and burst open the thermometer.Biomedical removed all thermometers of this type from the patient care areas.Biomedical to submit and report to mfg for analysis.Manufacturer response for non-touch thermometer, arc instatemp (per site reporter): awaiting response form mfg.

• Brand Name: ARC INSTATEMP NON-TOUCH THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): ARC DEVICES USA INC; 1200 n. federal hwy, suite 207; boca raton FL 33432
• MDR Report Key: 7406314
• MDR Text Key: 104673248
• Report Number: 7406314
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/02/2018,04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1