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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. SKIN TEMPERATURE PROBE WARMER, INFANT RADIANT

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DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. SKIN TEMPERATURE PROBE WARMER, INFANT RADIANT Back to Search Results
Model Number V81-010400
Device Problems Improper Device Output (2953); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/01/2017
Event Type  malfunction  
Event Description
The patient's post-op temperature was reading very low. A bair hugger was in use reading 36 degrees and the adult skin temperature probe was reading 32 degrees. The skin temperature probe was placed on the back.
 
Manufacturer Narrative
Root cause: a root cause could not be identified because no discrepancies were found with the defective sample or in the documentation on hand. Corrective action: a corrective action was not taken due to the root cause determination. Investigation summary an internal complaint ((b)(4)) was received reporting that an adult skin temperature probe (part number v81-010400) detected a temperature reading during use on a post-operative patient. A sample was reported to be available for evaluation. The sample was received and evaluated. A functional test was performed on the device by itself as well as with an interface cable. The results were within the device specification of 1344-1366 ohm. The functional tests confirmed that there were no discrepancies with the defective sample. The device history record for the reported lot number was reviewed. No issues were reported during the manufacturing process. The sub-assembly work orders also were reviewed; no functional issues were identified. An inventory check of the work order in process also was conducted. No functional issues were identified. A two-year review of complaints was completed and three similar complaints were identified. These complaints were for a different part number and have been closed and verified. A two-year review of material review reports (mrr) also was conducted. Mrrs that have been generated due to functionality issues during the manufacturing process were identified. However, at this time, all reports have been properly closed and verified. Preventive action: a preventive action has not been taken due to the root cause determination. The investigation is complete at this time. If new and critical information is received, this report will be updated.
 
Manufacturer Narrative
Investigation summary: an internal complaint ((b)(4)) was received reporting that an adult skin temperature probe (part number v81-010400) detected a temperature reading during use on a post-operative patient. A sample was reported to be available for evaluation. As of the date of this report, the sample had not been received for evaluation. The investigation is ongoing at this time. When new and critical information is received, this report will be updated.
 
Event Description
The patient's post-op temperature was reading very low. A bair hugger was in use reading 36 degrees and the adult skin temperature probe was reading 32 degrees. The skin temperature probe was placed on the back.
 
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Brand NameSKIN TEMPERATURE PROBE
Type of DeviceWARMER, INFANT RADIANT
Manufacturer (Section D)
DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.
global park, box 180-3006
602 parkway, la aurora
heredia, heredia 146
CS 146
Manufacturer (Section G)
DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L
global park, box 180-3006
602 parkway, la aurora
heredia, heredia 146
CS 146
Manufacturer Contact
sarah bennett
200 debusk lane
powell, TN 37849
8653626112
MDR Report Key6959283
MDR Text Key280744901
Report Number9613793-2017-00003
Device Sequence Number1
Product Code FMT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K925006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberV81-010400
Device Lot Number45126601
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/18/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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