MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC MEDLINE DIGITAL THERMOMETER ORAL LATEX FREE

Model Number REF MDS9950

Device Problem High Test Results (2457)

Patient Problem Test Result (2695)

Event Date 03/14/2015

Event Type  Injury  

Event Description

Each newborn baby is given his/her own oral thermometer for use during baby's hospital stay.This baby's thermometer showed baby's temp to be >100 degrees repeatedly, resulting in baby staying in hosp for 10 days, undergoing multiple tests to determine cause of "fever" including blood draws, urinary catheterization, and lumbar puncture, and multiple iv antibiotics including gentamycin.It was ultimately discovered that the thermometer was giving falsely elevated readings.When baby's temp was taken with other thermometers the results were normal.Dates of use: (b)(6) 2015-(b)(6) 2015.Diagnosis or reason for use: vital signs monitoring (temp).Event abated after use stopped or dose reduced: yes.

• Brand Name: MEDLINE DIGITAL THERMOMETER ORAL LATEX FREE
• Type of Device: THERMOMETER
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC; mundelein IL 60060
• MDR Report Key: 4728305
• MDR Text Key: 18088964
• Report Number: MW5042251
• Device Sequence Number: 1
• Product Code: FLL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF MDS9950
• Device Catalogue Number: MDS 9950
• Device Lot Number: 14269326
• 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): Hospitalization; Other
• Patient Age: 1 DA
• Patient Weight: 4