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

Model Number 81-02S412

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2019

Event Type  malfunction  

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 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
• Type of Device: 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
• 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 Key: 9327536
• MDR Text Key: 179530268
• Report Number: 9613793-2019-00005
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00749756812573
• UDI-Public: 00749756812573
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 81-02S412
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2019
• 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 Number: 1