MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PHILIPS; THERMOMETER, ELECTRONIC, CLINICAL

Model Number RECTAL TEMPERATURE PROBE

Device Problem Low Readings (2460)

Patient Problems Arrhythmia (1721); Fever (1858); High Blood Pressure/ Hypertension (1908); Shaking/Tremors (2515)

Event Date 09/02/2022

Event Type  malfunction  

Event Description

Pt temperature trending upward, has been febrile previously.Rectal probe began to increase quickly while pt showing signs of neuro storming (increased bp, hr, tremors).Dr.Notified.Probe read as high as 42.7.Rectal probe changed before gastric lavage, tympanic, and axillary temp checked as well.All read 36.4-.36.5.First probe appeared to malfunction.Fda safety report id# (b)(4).

• Brand Name: PHILIPS
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC
• MDR Report Key: 15380617
• MDR Text Key: 299599946
• Report Number: MW5111925
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RECTAL TEMPERATURE PROBE
• Device Catalogue Number: RECTAL TEMPERATURE PROBE
• Device Lot Number: 21B35774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Sex: Male
• Patient Weight: 25 KG
• Patient Ethnicity: Hispanic
• Patient Race: White