MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. RECTAL TEMPERATURE PROBE CONNECTION; THERMOMETER, ELECTRONIC, CLINICAL

Lot Number 20040902

Device Problems Loose or Intermittent Connection (1371); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Fever (1858)

Event Date 07/28/2022

Event Description

Rectal temp probe connector to spacelabs monitor.Connection bad causing inaccurate temperature reading.When connection was inspected and moved the temp probe began reading the correct temperature which was extremely high and out of normal range.Fda safety report id# (b)(4).

• Brand Name: RECTAL TEMPERATURE PROBE CONNECTION
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN 55442
• MDR Report Key: 15192735
• MDR Text Key: 297633155
• Report Number: MW5111347
• 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: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Lot Number: 20040902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male