MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC INFANT HEEL WARMER; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number V1146-010

Device Problems Insufficient Heating (1287); Device Operates Differently Than Expected (2913)

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

Event Date 02/24/2017

Event Type  malfunction  

Event Description

Several heel warmers did not activate as expected.

• Brand Name: INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 1500 waukegan rd.; waukegan IL 60085
• MDR Report Key: 6431431
• MDR Text Key: 70785275
• Report Number: 6431431
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2017

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: No Information
• Device Model Number: V1146-010
• Device Catalogue Number: V1146-010
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1