MAUDE Adverse Event Report: SECURITAS HEALTHCARE SECURITAS HEALTHCARE; 54336 ARIAL CALL STATION

Model Number	54336
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	02/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Call light was turned on at 12:45:12 and turned itself off at 12:45:15.At 12:47:35 we can see on the cameras that the resident is on the floor scooting out of her room.Call light turns itself back on at 12:48:13.Nobody else went in the room before this.Staff turns it off at 12:50:10.Dome light was visible in camera view and confirmed all of this information.
Additional Manufacturer Narrative
Dear mr.(b)(6), on 6/11/2024, securitas healthcare (sh) received a complaint form from your facility reporting of a device malfunction.You reported an incident having occurred on (b)(6); wherein a resident fell and hit their head.The system registered that the resident called for help at 12:45:12 and cleared at 12:45:15.At 12:48:13 a second alarm is registered on the system for the same call point and this alarm remained active.Securitas healthcare subsequently evaluated the call point that was said to be involved in this incident following its return on rma# 00282278.Findings from the evaluation are that the call point is operating as designed.The timeline of events of the incident provided above suggests that the system alarmed and remained in alarm upon receipt of a second alarm transmission from the call point.This behavior is intended so that an alarm will still be provided to staff even in the unlikely scenario where the initial alarm transmission is missed by the system.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 thornapple manor's device malfunctioned.Additionally, a review of customer complaints related to model 54336 is extremely low.

• Brand Name: SECURITAS HEALTHCARE
• Common Device Name: 54336 ARIAL CALL STATION
• Manufacturer (Section D): SECURITAS HEALTHCARE; 4600 vine street; lincoln; NE 68503
• Manufacturer (Section G): SECURITAS HEALTHCARE; 4600 vine street; lincoln NE 68503
• MDR Report Key: 19634151
• Report Number: 1929691-2024-00003
• Device Sequence Number: 7137641
• Product Code: IQA
• UDI-Device Identifier: 00840948100666
• UDI-Public: 00840948100666
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 06/28/2024

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: 54336
• Device Catalogue Number: 54336
• Device Lot Number: 610314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 06/28/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic
• Patient Race: White