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U.S. Department of Health and Human Services

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

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HILL-ROM CARY VOALTE NURSE CALL; SYSTEM, COMMUNICATION, POWERED Back to Search Results
Model Number 3.9
Device Problem Device Alarm System (1012)
Patient Problem Fall (1848)
Event Date 05/11/2023
Event Type  malfunction  
Event Description
The customer reported an unwitnessed patient fall occurred on (b)(6) 2023 and the bed exit alarm did not annunciate on the nurse call communication system.The patient then attempted to call the nurse¿s station using the pillow speaker and the call did not alert at the nurse¿s station.At the time of the initial report, the customer did not indicate whether the patient was injured, and no medical intervention was reported.Attempts to obtain additional information from the customer were unsuccessful.This incident was captured under hillrom complaint ref # (b)(4).
 
Manufacturer Narrative
The navicare® nurse call¿ (nnc) 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.The device instructions for use (ifu) state the following about system alerts: ¿a system alert provides information about a component that is disconnected from the system.Notify your system administrator of every system alert.¿ the nurse call system is designed to place system alerts on the primary staff consoles, and other applicable user interfaces, when there is a malfunction.A lost rcb call system alert is an indication to the staff that the room, component, or service has a problem and requires servicing.The system alert provides staff the opportunity to implement back up protocols for patient communication.Troubleshooting activities performed by hillrom determined the cause of the event was due to a lost room control board (rcb) call at the grs10 console location.A review of the nurse call log file showed a lost rcb call system alert was generated on 16apr2023 and never cancelled.The reported issue was resolved by recovering the rcb and calls worked as intended.In this event, there was an allegation of an unwitnessed patient fall and the bed exit alarm did not annunciate at the nurse¿s station.However, at the time of the initial report, there was no indication of an injury to the patient, no medical intervention was reported, and no additional information could be obtained from the customer.Based on the limited details provided, there is no indication that a serious injury occurred.It is unlikely, based on troubleshooting activities, that a malfunction or defect of the device caused or contributed to the patient¿s fall.The cause of the event is likely due to use error (failure to respond to lost rcb call system alert).However, if a bed exit alert not annunciating at the nurses station due to a lost rcb were to recur, it could result in a serious injury or death, therefore hillrom is reporting this event.
 
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Brand Name
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
1225 crescent green dr., suite 300
cary, NC 27518
8129310130
MDR Report Key17080180
MDR Text Key316713246
Report Number2027454-2023-00045
Device Sequence Number1
Product Code ILQ
UDI-Device Identifier00887761985209
UDI-Public00887761985209
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number3.9
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/11/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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