MAUDE Adverse Event Report: MCROBERTS SECURITY TECHNOLOGIES MYCHILD INFANT SECURITY SYSTEM; CLAMP, UMBILICAL

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 06/24/2018

Event Type  malfunction  

Event Description

Mcroberts infant security failed to work when tested.

• Brand Name: MYCHILD INFANT SECURITY SYSTEM
• Type of Device: CLAMP, UMBILICAL
• Manufacturer (Section D): MCROBERTS SECURITY TECHNOLOGIES; 46 throckmorton street; freehold NJ 07728
• MDR Report Key: 7884631
• MDR Text Key: 120541502
• Report Number: 7884631
• Device Sequence Number: 1
• Product Code: HFW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2018
• Date Report to Manufacturer: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1