MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC RIGHTTEMP; THERMOMETER, ELECTRONIC, CLINICAL

Catalog Number MDS8700

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem Insufficient Information (4580)

Event Date 10/06/2020

Event Type  malfunction  

Event Description

A medline industries righttemp tympanic thermometer malfunctioned and temperatures were noted to be reading as falsely elevated.Following the incident, the device was taken out of service.It is unsure for how long this malfunctioning with the righttemp thermometer was happening or how many patients it may have affected.Once the issue was recognized, all patients with recent febrile temps in triage were rechecked.

• Brand Name: RIGHTTEMP
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC; three lakes drive; northfield IL 60093
• MDR Report Key: 10875016
• MDR Text Key: 217328489
• Report Number: 10875016
• 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: 11/12/2020,11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MDS8700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/12/2020
• Date Report to Manufacturer: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1