MAUDE Adverse Event Report: STANLEY SECURITY SOLUTIONS, INC. M200-C FALL MONITOR (M200 WITH CLOSED BATTERY COMPARTMENT COVER); MONITOR, BED PATIENT

Model Number	M200-C
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported of nearly 30 instances of bed alarm's batteries were not able to hold a charge and were overheating while in use with patients.The span of these incidents included several lot numbers and in several different locations.No evidence of harm to any patient was noted.

• Brand Name: M200-C FALL MONITOR (M200 WITH CLOSED BATTERY COMPARTMENT COVER)
• Common Device Name: MONITOR, BED PATIENT
• Manufacturer (Section D): STANLEY SECURITY SOLUTIONS, INC.; 4600 vine street; lincoln NE 68503
• MDR Report Key: 13886131
• Report Number: 13886131
• Device Sequence Number: 1468004
• Product Code: KMI
• UDI-Device Identifier: 00840948101595
• UDI-Public: (01)00840948101595
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/07/2022
• Report Date (Section F): 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M200-C
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/16/2022