FDA Adverse Event No answer provided Summary report: N

DRAGER RADIANT WARMER BED TEMPERATURE PROBE

MDR report key: 13691863 · Received March 8, 2022

Report

Report Number
13691863
Event Type
No answer provided
Date Received
March 8, 2022
Date of Event
December 24, 2021
Report Date
February 22, 2022
Manufacturer
DRAEGERWERK AG & CO. KGAA
Product Code
FLL
Report Source
User Facility report
Reporter Location
PA
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

NOTICED INFANT WAS WARM IN AFTERNOON CARE. RN TRIED TO WEAN THE BED TEMPERATURE DOWN. INFANT WAS WARMER AT NEXT CARE TIME. RN ATTEMPTED TO WEAN BED TEMPERATURE A SECOND TIME. RN CHECKS TEMP AN HOUR LATER, TEMPERATURE IS 101.4 AND TEMP PROBE IS ON CORRECTLY BUT READING COLD AND BED IS AT HIGHEST HEAT INTENSITY. PRODUCT SAVED FOR PRODUCTS NURSE. MANUFACTURER AWARE OF ISSUE. NEW PROBE USED, ISSUE DID NOT REPEAT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1496151 DRAGER RADIANT WARMER BED TEMPERATURE PROBE THERMOMETER, ELECTRONIC, CLINICAL FLL DRAEGERWERK AG & CO. KGAA

Patients

Seq Age Sex Outcome Treatment
1 Unknown