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

Model Number 72100

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Fall (1848)

Event Date 09/06/2016

Event Type  malfunction  

Manufacturer Narrative

Report from bio-med staff at facility indicates device was tested after incident and no issues were found.Device evaluated by manufacturer and no device failures/faults could be detected.Batteries were tested and voltages were found to be within normal operating ranges.Additional training and documentation has been provided to facility staff to show proper usage and procedures.

Event Description

Patient was reaching for his bedside table when his legs slid off the side of the bed and the rest of his body followed.Bed check did not sound.When the device was checked, it was found to be malfunctioning.Patient suffered small skin tear to scapular region.

• 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: 6113560
• MDR Text Key: 60424072
• Report Number: 1929691-2016-00004
• 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: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72100
• Device Catalogue Number: 72100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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: 64 YR
• Patient Weight: 63