MAUDE Adverse Event Report: SECURITAS HEALTHCARE SECURITAS HEALTHCARE; CHAIR PAD

Model Number	73030
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	09/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2025, (b)(6).Re: medwatch form mw5163217.Dear (b)(6), on (b)(6) 2024, securitas healthcare (sh) received a medwatch report from your facility reporting of device malfunction.You reported an incident having occurred in (b)(6) 2024.Further you reported that the person involved sustained multiple right sided subdural hematomas.(b)(6) subsequently reached out to you on december 27th and january 6th and requested that the devices in question be returned to securitas healthcare for evaluation.However, to date, none of the reported equipment has been returned.As the devices in question have not been returned to date - i am closing out this filing citing no further action required by securitas healthcare.As a reminder, the testing operation defined on page 40 of the user manual outlines the proper testing protocol to be used when arming the pad and m210 fall monitor.A copy of this user manual is included with this letter for reference.If you have any questions, please feel free to contact me at (b)(6).Sincerely, (b)(6) director of quality and regulatory compliance.
Event or Problem Description
Chair alarm pad wedged into the chair and did not alarm when the patient got up.The patient fell and sustained multiple right sided subdural hematomas.

• Brand Name: SECURITAS HEALTHCARE
• Common Device Name: CHAIR PAD
• Manufacturer (Section D): SECURITAS HEALTHCARE; 4600 vine street; lincoln NE 68503
• Manufacturer (Section G): SECURITAS HEALTHCARE; 4600 vine st; lincoln NE 68503
• Manufacturer Contact: garth jack ; 4600 vine st; lincoln, NE 68503 ; 8016870327
• MDR Report Key: 21440274
• Report Number: 1929691-2025-00001
• Device Sequence Number: 11913193
• Product Code: KMI
• UDI-Device Identifier: 00840948102516
• UDI-Public: 00840948102516
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/21/2025

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: 73030
• Device Catalogue Number: 73030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White