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

Model Number 3.9

Device Problem Delayed Alarm (1011)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2022

Event Type  malfunction  

Manufacturer Narrative

The hillrom nurse call system provides visual and/or audible event alert notifications via designated communication devices (main console, ancillary staff console, hallway dome lights, mobile phones).Locating is an advanced feature of the nurse call system.When real-time staff locating badges are used in conjunction with the nurse call system, it allows staff to have the ability to quickly locate and communicate with a fellow staff member.Additionally, locating badges equipped with a duress button, allow a staff member to initiate a duress (urgent) call/alert for assistance in the event the caregiver is not in close proximity to a nurse call system station/button.A review of the nurse call log files showed that a duress call was placed while the caregiver¿s locating badge was transitioning between locating monitors, and the call location was identified as the previous patient room the caregiver was located in.Additionally, the locating monitor in the room associated with the event did not recognize the caregiver¿s locating badge as being present until forty-five seconds after the caregiver entered the room.Monitors send infrared signals to the located badges that enable badges to accurately broadcast their locations.A locating badge typically transmits its location to the locating monitor every four to six seconds.Monitors can be powered by lithium d-cell batteries, or, optionally, by a power adapter.Troubleshooting determined that the bed exit function worked as intended and the issue was due to a non functional monitor.The associated monitor was replaced, which resolved the issue.The customer confirmed there was no injury as a result of this event.If the event of a duress call displaying at an incorrect location were to recur it is likely to result in serious injury or death, as the duress alert is commonly used in the event of an emergency.

Event Description

The customer reported that a staff duress call alerted showing the incorrect room location.The customer also reported that there was a patient fall associated with this event, however, the customer confirmed there was no injury from the fall.This event has been captured under hillrom complaint ref # (b)(4).

• Brand Name: NURSE CALL INSTALLATION
• 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 ; 1225 crescent green dr., suite 300; cary, NC 27518 ; 8129310130
• MDR Report Key: 16021161
• MDR Text Key: 306411460
• Report Number: 2027454-2022-00027
• Device Sequence Number: 1
• Product Code: ILQ
• 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: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 3.9
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1