MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS ESOPHAGEAL/RECTAL TEMPERATURE PROBE; THERMOMETER, ELECTRONIC, CLINICAL

Catalog Number 21090A

Device Problem High Test Results (2457)

Patient Problem No Information (3190)

Event Date 07/08/2017

Event Type  malfunction  

Event Description

Multiple pt's temperature rectal probes were malfunctioning, specifically reading higher values.For example 105.7, 107.7, or 104.6 degrees when the patient's actual temps were significantly lower.This has been leading to inappropriate interventions.

• Brand Name: ESOPHAGEAL/RECTAL TEMPERATURE PROBE
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 6897462
• MDR Text Key: 87512863
• Report Number: 6897462
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 10/16/2019
• Device Catalogue Number: 21090A
• Device Lot Number: 16L94281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1