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U.S. Department of Health and Human Services

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

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ARC DEVICES USA INC. ARC INSTATEMP; THERMOMETER, ELECTRONIC, CLINICAL Back to Search Results
Model Number CF1-0196
Device Problems Nonstandard Device (1420); Product Quality Problem (1506); Battery Problem (2885); Manufacturing, Packaging or Shipping Problem (2975); Power Problem (3010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/11/2017
Event Type  malfunction  
Event Description
Customer states the thermometer was found exploded in the bathroom closet where the unit was sitting unattended.No one was hurt.Arc requested the customer to return the product.A lab analysis for this type of failure was performed on similar device.The analysis of the batteries included an optical microscopy, ct scan and 2d x-ray and indicated the failure was due to a single component (battery) malfunction.Report, attached.The suspect batteries have not been used in production since 17 july 2015.
 
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Brand Name
ARC INSTATEMP
Type of Device
THERMOMETER, ELECTRONIC, CLINICAL
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 Key6940411
MDR Text Key90157253
Report Number3011197139-2017-00108
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152905
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 10/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Patient Family Member or Friend
Device Model NumberCF1-0196
Device Catalogue NumberCF1-0196
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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