MAUDE Adverse Event Report: HILL-ROM CARY COMLINX NCM; VOALTE NURSE CALL; SYSTEM, COMMUNICATION, POWERED

Model Number 4.0

Device Problem Defective Alarm (1014)

Patient Problem Fall (1848)

Event Type  malfunction  

Manufacturer Narrative

The nurse call system is a comprehensive communication and information management system that helps caregivers provide the best possible care to patients in the most efficient manner.The system facilitates communication within a nursing unit.Caregivers have the ability to quickly locate and communicate with a fellow staff member, and patients can easily communicate with caregivers, the nursing station, or directly to their primary caregiver.When a bed is used in conjunction with voalte nurse call, the bed¿s exit alert notification, in addition to alerting at the bedside, is routed to designated communication devices (nurse console, patient station, dome light, mobile phone, etc.) and provides a visual and/or audible event alert notification at the designated device.The voalte nurse call instructions for use notes ¿the nurse call system is designed to be used only as a secondary alarm system for bed exit alarms.It should never be used as the primary bed exit alarm system.Additional information received from the customer confirmed there was no patient injury from the fall.The customer stated that during the time/days surrounding the event, the locating feature was/is inaccurate.When staff are standing in the hallway (outside rooms) the staff location dome light will illuminate indicating that a staff member is inside the nearby room.The following rooms were noted to be included in the allegation 719, 720, 724 as well as rooms on a different unit rooms 732-741.At the time of this call, the customer stated that locating seemed to currently be working properly.It is noted that the bed provided notification via audible alert at the bed side and illumination of the dome light at the appropriate location as acknowledged by the customer and there was no patient injury.Follow up information from the customer found when staff are standing in the hallway (outside rooms) the staff location dome light will illuminate indicating that a staff member is inside the nearby room.Hillrom is unable to determine if the device contributed to the patient fall due to lack of clarifying information from the customer regarding the report of the nurse not being alerted by the nurse call system.Therefore, hillrom is cautiously reporting this event due to the potential for serious injury if the reported problem were to recur.

Event Description

The customer reported an incident occurred where a patient fell out of bed and the nurse did not respond to the bed exit due to not being alerted by the voalte nurse call system.The customer acknowledged an audible and visual notification of the location was received by the bed exit alarm and illumination of the dome light.Follow up information from the charge nurse confirmed there was no patient injury associated with the reported event.This event has been captured under hillrom complaint ref # : (b)(4).

• Brand Name: COMLINX NCM; VOALTE NURSE CALL
• Type of Device: SYSTEM, COMMUNICATION, POWERED
• Manufacturer (Section D): HILL-ROM CARY; 1225 crescent green dr., suite 300; cary NC 27518
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 27518 ; 8129310130
• MDR Report Key: 15183675
• MDR Text Key: 303317369
• Report Number: 2027454-2022-00002
• Device Sequence Number: 1
• Product Code: ILQ
• UDI-Device Identifier: 00887761995079
• UDI-Public: 00887761995079
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4.0
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1