MAUDE Adverse Event Report: STANLEY HEALTHCARE CHAIR ALARM MODEL 26200

Model Number 26200

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/23/2016

Event Type  malfunction  

Event Description

Chair pad/alarm/wall connection was all connected.When white alarm box was pressed, it was activated, and activated the red light on the wall.However, upon pressing the chair alarm pad, it did not make a sound.Pt info not available.

• Brand Name: CHAIR ALARM MODEL 26200
• Type of Device: CHAIR ALARM MODEL 26200
• Manufacturer (Section D): STANLEY HEALTHCARE; lincoln NE 68503
• MDR Report Key: 6099098
• MDR Text Key: 59903992
• Report Number: MW5065982
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26200
• Device Lot Number: UNAVAILABLE
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1