SECURITAS HEALTHCARE
Received Jun 28, 2024 · Event occurred Feb 18, 2024
Report 1929691-2024-00003 · MDR key 19634151
Device
Generic name
54336 Arial Call Station
Manufacturer
Securitas HealthcareModel number
54336Catalog number
54336
Lot number
610314
Product problems
- Labelling, Instructions for Use or Training Problem
- Labelling, Instructions for Use or Training Problem
Patient
NA · Prefer Not To Disclose
- Head Injury
- Head Injury
Narrative
Description of Event or Problem
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.
Remedial action
- Inspection