FDA Adverse Event Malfunction Summary report: N

*

MDR report key: 1153090 · Received September 8, 2008

Report

Report Number
1153090
Event Type
Malfunction
Date Received
September 8, 2008
Report Date
September 5, 2008
Manufacturer
MEDLINE INDUSTRIES, INC.
Product Code
MPO
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA, US

Narratives

Description of Event or Problem · 1

INFANT HEEL WARMER PRODUCT # MDS138007 IS THE ONE THAT WAS TESTED ON A PATIENT DIGITAL THERMOMETER. THE TEMPERATURE REACHED 109*F THEN THE THERMOMETER SHUT DOWN. THE LABEL ON THE PACKAGING STATES THAT THE TEMPERATURE WILL REACH UP TO 105*F. THE MANUFACTURER'S RESPONSE WAS: THE HEEL WARMERS WERE TESTED TWO WAYS. ONE WAS TO WRAP THE PACK AROUND THE TEMPERATURE PROBE SO THAT THE PROBE WAS SURROUNDED ON ALL SIDES. THIS PROVIDED THE HIGHER TEMPERATURE RANGE. THE SECOND WAY WAS TO PLACE THE WARMER ON TOP OF THE PROBE. THIS IS TYPICALLY HOW THE WARMERS ARE USED. THIS WAY PROVIDED A TEMPERATURE IN THE 103 - 105 DEGREE RANGE. I THINK THE ISSUE COMES UP WITH PREMATURE BABIES. DUE TO THE FACT THAT THE INFANTS ARE SO SMALL, THE CLINICIAN COULD POSSIBLY USE THE WARMER PACK IN A WRAPPING STYLE. WE ARE EVALUATING OUR PACKAGING AND VERBIAGE.====================== MANUFACTURER RESPONSE FOR HEEL WARMER, INFANT, (BRAND NOT PROVIDED)======================THE HEEL WARMERS WERE TESTED TWO WAYS. ONE WAS TO WRAP THE PACK AROUND THE TEMPERATURE PROBE SO THAT THE PROBE WAS SURROUNDED ON ALL SIDES. THIS PROVIDED THE HIGHER TEMPERATURE RANGE. THE SECOND WAY WAS TO PLACE THE WARMER ON TOP OF THE PROBE. THIS IS TYPICALLY HOW THE WARMERS ARE USED. THIS WAY PROVIDED A TEMPERATURE IN THE 103 - 105 DEGREE RANGE. I THINK THE ISSUE COMES UP WITH PREMATURE BABIES. DUE TO THE FACT THAT THE INFANTS ARE SO SMALL, THE CLINICIAN COULD POSSIBLY USE THE WARMER PACK IN A WRAPPING STYLE. WE ARE EVALUATING OUR PACKAGING AND VERBIAGE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 * HEEL WARMER, INFANT MPO MEDLINE INDUSTRIES, INC. * 08066

Patients

Seq Age Sex Outcome Treatment
1 *