MAUDE Adverse Event Report: CVS HEALTH (180 INNOVATIONS) / 180 INNOVATIONS LLC FLEXIBLE TIP DIGITAL THERMOMETER (5 SECOND READING); THERMOMETER, ELECTRONIC, CLINICAL

Model Number KD-1760

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2020

Event Type  malfunction  

Event Description

False readings on device; while providing home care to elderly patient, a brand new cvs health-branded digital thermometer provided inconsistent and questionable temperature readings.Replaced the battery with a fresh one, problem appeared to resolve for several hours and then returned.(b)(6) search revealed many identical or similar problems with these thermometers, indicating a potential manufacturing quality problem.Fda safety report id# (b)(4).

• Brand Name: FLEXIBLE TIP DIGITAL THERMOMETER (5 SECOND READING)
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): CVS HEALTH (180 INNOVATIONS) / 180 INNOVATIONS LLC
• MDR Report Key: 10224014
• MDR Text Key: 197612529
• Report Number: MW5095338
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00050428250440
• UDI-Public: (01)00050428250440
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: KD-1760
• Device Lot Number: 2004
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 93 YR
• Patient Weight: 49