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

Model Number 72100

Device Problem Defective Alarm (1014)

Patient Problem Fall (1848)

Event Date 09/03/2017

Event Type  malfunction  

Manufacturer Narrative

Re: medwatch form (b)(4).Dear (b)(6), on 1/8/2018, stanley healthcare (sh) received a medwatch report from your facility reporting device malfunctions.You reported an incident having occurred on approximately (b)(6) 2017.No injury was reported in the mdr filing.To date, none of the reported equipment has been returned to sh for further evaluation as requested.In the past, our company has sent compliance, engineering and product solutions staff to your facility to discuss recurring issues and observe the system in use.We have provided suggested best practices for your staff to adhere to ensuring our product is used properly.As my calls and emails have not been returned - i am closing out this filing citing no further action required by stanley healthcare.I would like to remind you of the following warning statements in the bed-check® cordless user guide: test the bed-check® monitor and sensormat® pad before each use and inspect the cords and pads for signs of damage.Replace any components with signs of wear or damage immediately.Check that the transmitter is switched on and that the status led on the monitor flashes green for at least 1 second when the reset button is pressed, or the status led flashes green for 0.5 seconds once per minute to indicate that it is monitoring the person.Operators of this equipment must be familiar with the functions and usage as described in this manual, and must be properly trained in the patient care policies and procedures of the facility.If you have any questions, please feel free to contact me at (b)(4).Sincerely, (b)(4), director of compliance.[(b)(4)].

Event Description

Patient was placed on chair with chair check inplace and activated.Five minutes later, patient slid from chair to the floor and the chair check did not alarm.The patient suffered no injuries.

• Brand Name: BED CHECK
• Type of Device: MONITOR BED PATIENT
• Manufacturer (Section D): STANLEY SECURITY SOLUTIONS; 4600 vine street; lincoln NE 68503
• Manufacturer (Section G): STANLEY SECURITY SOLUTIONS; 4600 vine street; lincoln NE 68503
• Manufacturer Contact: garth jack ; 4600 vine street; lincoln, NE 68503 ; 4027429335
• MDR Report Key: 7667663
• MDR Text Key: 113642687
• Report Number: 1929691-2018-00007
• 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
• Reporter Occupation: Risk Manager
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 09/15/2017,09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 72100
• Device Catalogue Number: 14082705C1
• 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: 09/15/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2016
• 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: 66 YR