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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARC DEVICES USA, INC. ARC INSTATEMP DIGITAL NON-TOUCH FOREHEAD THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL
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ARC DEVICES USA, INC. ARC INSTATEMP DIGITAL NON-TOUCH FOREHEAD THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL Back to Search Results
Device Problems Material Fragmentation (1261); Leak/Splash (1354); Noise, Audible (3273); Explosion (4006)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/06/2019
Event Type  malfunction  
Event Description
The submitter is reporting the unit for posing a fire and injury hazard.He heard a loud noise and when he went into his child¿s room he noticed pieces of the unit across the floor.He indicated that the unit was on the changing table and he noticed battery acid had spattered over the changing table and his child¿s blankets nearby.He said the unit was not being used when the incident occurred.He indicated that the batteries came with the unit.The submitter¿s wife contacted the firm and reported the incident.The firm told her the unit was a 2015 model and that the batteries were old, which may have caused the incident.The firm has offered a refund.The submitter believes the product should be investigated to prevent injuries to an infant.He¿s concerned that an incident can occur while a parent uses the unit on their child.Product category: baby; product type: nursery equipment & supplies; retailer: (b)(6); purchase date: 9/1/2018, this date is an estimate.The product was damaged before the incident: no.The product was modified before the incident: no.
 
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Brand Name
ARC INSTATEMP DIGITAL NON-TOUCH FOREHEAD THERMOMETER
Type of Device
THERMOMETER, ELECTRONIC, CLINICAL
Manufacturer (Section D)
ARC DEVICES USA, INC.
MDR Report Key8350801
MDR Text Key136517548
Report NumberMW5084157
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 02/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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