• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH NOVAPLUS INFANT HEEL WARMER; HOT DISPOSABLE PACK

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CARDINAL HEALTH NOVAPLUS INFANT HEEL WARMER; HOT DISPOSABLE PACK Back to Search Results
Catalog Number V11460-010
Device Problems Product Quality Problem (1506); Use of Device Problem (1670); Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 06/05/2017
Event Type  malfunction  
Event Description
These infant heel warmers are very difficult to use.It takes an extreme amount of pressure to break them up and then sometimes they break open, which is what happened to this device.Sometimes we are actually unable to break up the device to activate the heat element, so we move on to another one.There are numerous individual devices that have been defective or unable to break or opened upon breaking.We have a box in our neonatal intensive care unit (nicu) that we are collecting those that have malfunctioned.I grabbed one out of that box to initiate this report.I am not certain what is wrong with the one that i have.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NOVAPLUS INFANT HEEL WARMER
Type of Device
HOT DISPOSABLE PACK
Manufacturer (Section D)
CARDINAL HEALTH
1500 waukegan rd.
waukegan IL 60085
MDR Report Key6666548
MDR Text Key78378795
Report Number6666548
Device Sequence Number1
Product Code MPO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Catalogue NumberV11460-010
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/22/2017
Event Location Hospital
Date Report to Manufacturer06/22/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NOT APPLICABLE.
-
-