MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. HEEL WARMER; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Catalog Number MDS138009

Device Problems Overheating of Device (1437); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2019

Event Type  malfunction  

Event Description

Multiple events involving at least 3 infants whereby heel warmer packets exceeded the manufacturer's expected high temp of 104ºf to excess of 110°f (our thermometer's highest read is 110ºf).None were used on the infants and of the 10 saved devices one wasn't able to be activated.Device that could not be activated - lot# cn 19087a6 x1.All other devices: lot # cn 19068a5 x 6; lot # cn 19085a6 x 3.No patient harms.

• Brand Name: HEEL WARMER
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8981558
• MDR Text Key: 157130568
• Report Number: 8981558
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/08/2019

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: Health Professional
• Device Catalogue Number: MDS138009
• Device Lot Number: CD19065A5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/08/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9 DA
• Patient Weight: 1