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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA SA GLOBAL PARK GENERAL PURPOSE PROBE, 400 SERIES 9FR; THERMOMETER, ELECTRONIC, CLINICAL
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DEROYAL CIENTIFICA DE LATINOAMERICA SA GLOBAL PARK GENERAL PURPOSE PROBE, 400 SERIES 9FR; THERMOMETER, ELECTRONIC, CLINICAL Back to Search Results
Catalog Number 81-020409
Device Problem Display Difficult to Read (1181)
Patient Problem Alteration In Body Temperature (2682)
Event Date 11/07/2014
Event Type  malfunction  
Event Description
Post cardiac arrest patient active cooling patient as per targeted temperature management monitoring core temp via esophageal temperature probe nurse noted large difference between the esophageal-rectal temps and inner probe wires completely separated and pulled out of outer covering (probe portion no longer in patient).
 
Manufacturer Narrative
No further information is available at this time.Will provide follow ups if information becomes available.
 
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Brand Name
GENERAL PURPOSE PROBE, 400 SERIES 9FR
Type of Device
THERMOMETER, ELECTRONIC, CLINICAL
Manufacturer (Section D)
DEROYAL CIENTIFICA DE LATINOAMERICA SA GLOBAL PARK
602 parkway
p.o. box 180-3006
la aurora, heredia 146
CS  146
Manufacturer Contact
8653622333
MDR Report Key4359676
MDR Text Key5116095
Report Number9613793-2014-00006
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K925791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number81-020409
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/07/2014
Event Location Hospital
Date Manufacturer Received11/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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