MAUDE Adverse Event Report: STANLEY HEALTHCARE / STANLEY SECURITY SOLUTION, INC. WANDERGUARD BRACELET; PATIENT MONITOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/09/2017

Event Type  malfunction  

Event Description

Pt had wander guard in place, not in building when checked on by staff.Possible malfunction on pt.Removed bracelet.Bracelet not located.

• Brand Name: WANDERGUARD BRACELET
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): STANLEY HEALTHCARE / STANLEY SECURITY SOLUTION, INC.
• MDR Report Key: 6653068
• MDR Text Key: 78042069
• Report Number: MW5070489
• Device Sequence Number: 1
• Product Code: KMI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 32