MAUDE Adverse Event Report: SAFE SPACE SCAN TECHNOLOGY SAFE SPACE SCANNER MODEL 3S-07TW-WIFI; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 3S-07TW-WIFI

Device Problems Device Sensing Problem (2917); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problem Insufficient Information (4580)

Event Date 02/16/2021

Event Type  malfunction  

Event Description

Thermograph device problem.The (b)(6) donor site receptionist asked me to stand in front of their new automatic forehead-scanning thermometer to take my temperature.(later identified as safe space scanner model 3s-07twwifi) it lit up as i looked into the screen, about the size of a large cell phone or small tablet, i moved until my head shape matched the light outline on the screen, but it did not sense my temperature.The receptionist repeatedly told me to move "until the square turns green", but i could see no square.She continued to direct movements, without specifying how i was supposed to get it right.After at least eight attempts, she said "i know it works, let me show you" and she came around the counter, faced the machine and it promptly checked her temperature.I asked her to give me specific directions on how to make it work for me, and she continued to give non-specific and unhelpful directions, including move in closer, move back, hold still, move some more, make the square turn green, tilt your head down, tilt it up, i guess we tried another 6 times.She twisted the sensing head of the machine, but told the other employee not to twist it because that "would throw it off".She repeated her own temperature-taking and assured me that the machine was working correctly, but could not tell me how to make it work for me.Finally, when both of us were frustrated she agreed to take my temperature another way.Instead of using another no-contact infrared thermometer, she used an oral thermometer as i slightly raised the bottom of my mask.So then my blood pressure was high, and i was temporarily deferred.So i sent this: from: (b)(6), date: (b)(6) 2021, 9:00 pm.Subject: user directions for safe space scanner model 3s-07tw-wifi? mailed-by: (b)(6).I entered an establishment that uses your safe space scanner model 3s-07tw-wifi as the entry-level surface skin temperature measure, but for at least 14 attempts, we could not get the machine to register or transmit my temperature.The receptionist provided no specific directions and there was no placard explaining what i was to do, to permit an accurate reading.The receptionist said several times "just make the square turn green", which was not helpful, and eventually became annoying.It worked promptly when she stood in front of it.Another employee said they had been given no directions on how to use it, or how to direct visitors to use it.Immediately subsequent oral thermometer reading was normal, between 98-99 f please give me a link to the specific complete directions for use of this device, so i will know what to do next time, including: how far should my face be from the screen for it to work?; should i try to align my face, forehead and ears with the head-shaped outline on the screen?; do i need to hold still? for how long?; by appearance, it seemed to be on your floor stand, model bkt-v1 but was well below my eye level.Do i need to squat down to be temperature-sensed? is this a medical device, regulated, approved, or cleared by fda? if so, what class is it in, and what device category regulation covers it? how can the person being scanned determine whether facial recognition data is being captured, or if the facial characteristics of the person are being compared to a local or remote data-set? i look forward to your response.Your chat system did not answer even the first of these questions.Sincerely,(b)(6).As of today, no response.Fda safety report id# (b)(4).

• Brand Name: SAFE SPACE SCANNER MODEL 3S-07TW-WIFI
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): SAFE SPACE SCAN TECHNOLOGY; 2450 nw 36th st; unit a15; pompano beach FL 33073
• MDR Report Key: 11462352
• MDR Text Key: 239748054
• Report Number: MW5099921
• Device Sequence Number: 1
• Product Code: FLL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3S-07TW-WIFI
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 105