MAUDE Adverse Event Report: KENTEC MEDICAL, INC. ACCUTEMP PLUS TEMP PROBE COVER; WARMER, INFANT RADIANT

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

Patient Problem Fever (1858)

Event Date 08/02/2020

Event Type  No Answer Provided  

Event Description

Baby in giraffe isolette with an accutemp plus temp probe cover.Bed kept reporting the baby was cold.Baby's nurse found baby's temperature was taken and axillary temperature registered at 102.8.Nurse changed probe cover and allowed temperature in bed to lower, and unbundled baby.Baby's temperature was checked every 15 minutes until normal temperature was reached.

• Brand Name: ACCUTEMP PLUS TEMP PROBE COVER
• Type of Device: WARMER, INFANT RADIANT
• Manufacturer (Section D): KENTEC MEDICAL, INC.; 17871 fitch; irvine CA 92614
• MDR Report Key: 12083519
• MDR Text Key: 258887658
• Report Number: 12083519
• Device Sequence Number: 1
• Product Code: FMT
• 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: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1