MAUDE Adverse Event Report: SECURITAS HEALTHCARE SECURITAS HEALTHCARE; FALL MONITOR

Model Number	M210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6) 2025.(b)(6).Re: medwatch form 1929691-2025-00004.Dear mr.(b)(6), bsn, on (b)(6) 2025, securitas healthcare (sh) received a complaint form from your facility reporting of a device malfunction.You reported an incident having occurred on (b)(6), 2025; wherein a resident was found on the floor next to their recliner.The patient sustained a minor skin tear to left elbow.Securitas healthcare subsequently evaluated the fall monitor that was said to be involved in this incident following its return on rma# (b)(4).Findings from the evaluation are that the fall monitor is operating as designed.As a reminder, the testing operation defined on page 20 of the user manual outlines the proper testing protocol to be used when arming the m210 fall monitor.A copy of this user manual is included with this letter for reference.I am closing out this filing citing no further action required by securitas healthcare.Please note securitas actively monitors customer complaints, and there are no active investigations that would indicate lutheran medical centers device malfunctioned.If you have any questions, please feel free to contact me at (b)(6).Sincerely, (b)(6).
Event or Problem Description
Unassisted fall occurred when patient was found on the floor next to recliner.Patient sustained a minor skin tear to left elbow, cleansed and dressed.Facility staff reported the chair alarm was defective at the time of the event.

• Brand Name: SECURITAS HEALTHCARE
• Common Device Name: FALL MONITOR
• Manufacturer (Section D): SECURITAS HEALTHCARE; 4600 vine street; lincoln NE 68502
• Manufacturer (Section G): SECURITAS HEALTHCARE; 4600 vine street; lincoln NE 68502
• Manufacturer Contact: garth jack ; 4600 vine street; lincoln, NE 68502 ; 4027429335
• MDR Report Key: 23438797
• Report Number: 1929691-2025-00004
• Device Sequence Number: 4758607
• Product Code: KMI
• UDI-Device Identifier: 00840948102394
• UDI-Public: 00840948102394
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M210
• Device Catalogue Number: M210
• Device Lot Number: 000CCC22C6ED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Unknown
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White