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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM CARY VOALTE NURSE CALL; MONITOR, BED PATIENT

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HILL-ROM CARY VOALTE NURSE CALL; MONITOR, BED PATIENT Back to Search Results
Model Number 4.0
Device Problem Defective Alarm (1014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/31/2022
Event Type  malfunction  
Event Description
It was reported that a nurse found a patient, ¿unresponsive and flaccid¿ at the bedside the nurse pulled the hillrom code blue lever and the call bell system failed to send the alarm to the main desk or in the hallway.This event was captured under hillrom complaint ref # (b)(4).
 
Manufacturer Narrative
It was reported that a nurse found a patient, ¿unresponsive and flaccid¿ at the bedside the nurse pulled the hillrom code blue lever and the call bell system failed to send the alarm to the main desk or in the hallway.The nurse recognized the call bell system did not enunciate and was able to yell for help.The care team laid the patient flat, and the patient gained responsiveness with no additional medical intervention.The customer provided hillrom a confidential occurrence report of the event , which noted the patient¿s diagnosis as spinal cord syndrome, physician notified of event, ¿no apparent injury, ¿no treatment required¿ and ¿no follow up diagnostic evaluation needed.¿ additional follow up with the customer advised patients with spinal cord syndrome can, ¿sometimes go unresponsive due to their level of injury.¿ the patient is currently remaining on the ward.The voalte nurse call system provides a comprehensive communication and information system that places patient calls, staff calls as well as emergency and code blue calls.The system provides an annunciation of these calls at both room locations and primary (dedicated) nurse call stations.The nurse call system secondary notification provides visual and/or audible event alert notification via customer-designated nurse call communication devices.The location of these devices can be at a specific location or locations within the facility such as a nurse console located on a nursing-specific unit, a nurse console in the pbx department, a staff station located in a break room or hallway, mobile phones, etc.The notification routing of calls is configured with the naming convention, and audio and /or visual displays based on the customer's preference/request at the time of initial integration.Testing of both srs devices in the room was performed by a hillrom technician and the customer properties facility engineer and confirmed all 3 calls (code blue, staff assist, and staff emergency) functioned as designed.Although there was no malfunction found during the inspection, a malfunction cannot be ruled out in this instance.The technician reported the call on the primary nursing unit was visible and heard the audible alarm annunciate via the phone.There was no injury or alleged delay reported from the event; however, a missed code blue alert is likely to cause or contribute to a death or serious injury if it were to recur.Therefore hillrom is cautiously reporting this event.
 
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Brand Name
VOALTE NURSE CALL
Type of Device
MONITOR, BED PATIENT
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 Key15868708
MDR Text Key307743556
Report Number2027454-2022-00026
Device Sequence Number1
Product Code KMI
UDI-Device Identifier00887761995079
UDI-Public00887761995079
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number4.0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/31/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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