MAUDE Adverse Event Report: STANLEY HEALTHCARE SOLUTIONS HUGS INFANT TAG; SYSTEM, COMMUNICATION, POWERED

Model Number 865

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 07/20/2021

Event Type  malfunction  

Event Description

When night shift rn (registered nursed) verified hugs tag monitoring, infant not in hugs system.Tag verified on infant.Tag removed and taken out of service, new tag applied, and monitoring verified.

• Brand Name: HUGS INFANT TAG
• Type of Device: SYSTEM, COMMUNICATION, POWERED
• Manufacturer (Section D): STANLEY HEALTHCARE SOLUTIONS; 4600 vine street; lincoln NE 68503
• MDR Report Key: 12216790
• MDR Text Key: 263146456
• Report Number: 12216790
• Device Sequence Number: 1
• Product Code: ILQ
• 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: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 865
• 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: 07/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 DA