MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. GENERAL PURPOSE PROBE; THERMOMETER, ELECTRONIC, CLINICAL

Model Number	81-02S412
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458); Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: a root cause could not be determined.The defective unit was not returned for inspection and a lot number was not reported.Corrective action: due to the root cause determination, a corrective action was not taken.Investigation summary an internal complaint (call 48400) was received for a general purpose temperature probe (finished good 81-02s412, lot number not provided) that malfunctioned during use.Specifically, the probe was detecting a low temperature reading.The defective unit was not available for return.A work order review of the affected lot could not be performed because a lot number was not reported.Product in process was functionally inspected.A total of 125 units were tested and all wire sets were within specification.The previous two years of complaints were reviewed for complaints involving the general purpose probe product family.Five complaints for functional issues were identified as involving a general purpose probe.All five complaints have been investigated and verified.The investigation is complete at this time.If new and critical information becomes available, this report will be updated.
Event or Problem Description
The patient was an infant using a new rectal temperature probe for monitoring.The temperature was consistently reading low (35.3-35.7 c), so patient was placed on a bair hugger.Subsequently, the patient's blood pressure became lower and perfusion felt adequate; however, the monitor still read 35.6c.The temperature probe was switched with no change in temperature on monitor.The probe and cable were replaced, and the monitor read 37.3 c, which was more in line with how the patient appeared.

• Brand Name: GENERAL PURPOSE PROBE
• Common Device Name: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.; global park; box 180-3006, 602 parkway; la aurora, heredia, heredia 146 ; CS 146
• MDR Report Key: 9327536
• Report Number: 9613793-2019-00005
• Device Sequence Number: 16768916
• Product Code: FLL
• UDI-Device Identifier: 00749756812573
• UDI-Public: 00749756812573
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K925791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 81-02S412
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1