MAUDE Adverse Event Report: STANLEY SECURITY SOLUTIONS, INC. STANLEY M200; MONITOR, BED PATIENT

Model Number M200

Device Problems No Audible Alarm (1019); Break (1069)

Patient Problem Fall (1848)

Event Date 04/09/2019

Event Type  malfunction  

Event Description

Stanley bed alarm on patient for the purpose of alarming for fall prevention.Patient fell, bed alarm did not ring the alarm.Stanley rep contacted by nurse manager.Discovered the black cord used with the alarm was broken.Rep indicated this has happened before with this cord.

• Brand Name: STANLEY M200
• Type of Device: MONITOR, BED PATIENT
• Manufacturer (Section D): STANLEY SECURITY SOLUTIONS, INC.; 4600 vine st; lincoln NE 68503
• MDR Report Key: 8619323
• MDR Text Key: 145369830
• Report Number: 8619323
• Device Sequence Number: 1
• Product Code: KMI
• 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: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17520 DA