MAUDE Adverse Event Report: AERO HEALTHCARE; WARMER, INFANT HEEL

Lot Number 011415

Device Problem Temperature Problem (3022)

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

Event Date 03/04/2015

Event Type  malfunction  

Event Description

Our rns utilize heel warmers in nicu prior to sticking the infant.Some of the rns noticed that the warmers seemed "too hot".Our biomedical engineering dept was asked to test the warmers an their testing with a calibrated themometer measured a temp of 115.5 degrees.Product information for this device lists a maximum temp of 105 degrees.

• Type of Device: WARMER, INFANT HEEL
• Manufacturer (Section D): AERO HEALTHCARE; 616 corporate way; suite 6; valley cottage NY 10989
• MDR Report Key: 4619951
• MDR Text Key: 17224215
• Report Number: 4619951
• Device Sequence Number: 0
• Product Code: MPO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Lot Number: 011415
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2015
• Patient Sequence Number: 1