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

Model Number MDS138007

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2021

Event Type  malfunction  

Event Description

Heel warming pack for infant heels became an ice pack when activated instead of a heat pack, verified with 2nd rn and aprn device was becoming colder/forming ice pack not room temperature.

• Brand Name: INFANT HEEL WARMER
• Type of Device: INFANT HELL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 12165646
• MDR Text Key: 261483792
• Report Number: 12165646
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/07/2021

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 Model Number: MDS138007
• Device Lot Number: VN20170A2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2021
• Event Location: Other
• Date Report to Manufacturer: 07/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1