MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. GENERAL PURPOSE TEMPERATURE PROBE, SOFT; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 81-02S412

Device Problem Low Test Results (2458)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 08/11/2019

Event Type  malfunction  

Event Description

Patient was an infant using new rectal temperature probe for monitoring (aka general purpose temperature probe, soft 12 french, 400 series.Ref # 81-02s412).Temperature was consistently reading low (35.3 - 35.7c), so patient was placed on a bair hugger.Subsequently the patient's blood pressure became lower and perfusion felt adequate although the monitor still read 35.6.Temp probe was switched with no change in temperature on monitor, so cable was switched as well with again no change on monitor.I replaced probe and cable with the older style and the monitor then read 37.3, which was much more in line with how the patient appeared.

• Brand Name: GENERAL PURPOSE TEMPERATURE PROBE, SOFT
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk ln.; powell TN 37849
• MDR Report Key: 9172123
• MDR Text Key: 161729773
• Report Number: 9172123
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 81-02S412
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 DA