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

Device Problem Activation Problem (4042)

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

Event Date 10/12/2023

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the code blue pull switch needed to be replaced.The voalte nurse call system provides a comprehensive communication and information system that places patient calls, staff calls as well as emergency and code calls.The system provides an annunciation of these calls at both room locations and primary (dedicated) nurse call stations.The voalte® nurse call system also has an option for secondary notification calls to customer provided third-party products (e.G.Cell phones) where calls may also be forwarded.The secondary notification workflows are options offered to the facilities that the facility may or may not choose to implement as an ¿add on¿ to their primary notifications, depending on their facility¿s design and needs.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 nursing specific unit, nurse console in pbx department, a staff station located in a break room or hallway, mobile phones, etc.The notification routing of calls is configured with naming convention, audio and /or visual displays based on the customer preference/request at the time of initial integration.The hrc technician arranged to get change the pull switch for the customer to resolve the issue.Although there was no injury associated with this event, if the reported issue were to recur it could lead to injury or death.Therefore hillrom is reporting this complaint.

Event Description

Hillrom received a report from a hillrom technician stating the code blue did not ring.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• 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: estephania cardenas ; 1225 crescent green dr., suite 300; cary, NC 27518 ; 8129310130
• MDR Report Key: 18080669
• MDR Text Key: 327511869
• Report Number: 2027454-2023-00093
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1