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

Model Number 74050

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

In situ observation was performed at the user facility regarding the use of the equipment.Based on the description in this case, no product issue occurred and user error contributed to the event.User facility states that the monitor was observed to be flashing green before leaving the patient.This status indicator means that the unit was placed in hold mode, which allows caregivers to move a patient without generating an alarm.Hold mode expires after 2 minutes, and the report indicates that the fall likely occurred within this 2 minute period.

Event Description

From user facility medwatch report: "patient was repositioned in bed which resulted in the bed alarm going off.Before leaving the room, staff ensured that the bed check was activated by witnessing a blinking green light.A short time later, a loud noise was heard but no bed alarm.Staff responded and only after they were in the room did the bed alarm sound.The patient had fallen out of bed and the bed alarm sounded after a significant delay.Patient suffered minor skin tear to forehead and elbow.Ct head was negative.".

• Brand Name: BED CHECK
• Type of Device: MONITOR, BED PATIENT
• Manufacturer (Section D): STANLEY SECURITY SOLUTIONS, INC.; 4600 vine street; lincoln NE 68503
• Manufacturer (Section G): STANLEY SECURITY SOLUTIONS, INC.; 4600 vine street; lincoln NE 68503
• Manufacturer Contact: gina bennett ; 4600 vine street; lincoln, NE 68503 ; 4027429322
• MDR Report Key: 6357363
• MDR Text Key: 68363014
• Report Number: 1929691-2017-00007
• Device Sequence Number: 1
• Product Code: KMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 74050
• Device Catalogue Number: 74050
• Device Lot Number: A1016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR