MAUDE Adverse Event Report: HILL-ROM CARY VOALTE PATIENT SAFETY; VOALTE SMART SYNC VOALTE SMART SYNCV; MONITOR, BED PATIENT

Model Number 4.0

Device Problem Defective Alarm (1014)

Patient Problem Laceration(s) (1946)

Event Date 01/20/2023

Event Type  Injury  

Event Description

It was reported that with use of the nurse call, staff real time location system (rtls) badges were being inaccurately displayed in patient¿s room (while in the hall) and de-activating set bed alarms.This event led to a patient fall sustaining bruising and a minor laceration that was reapproximated with dermabond glue.This event was captured under hillrom complaint ref # (b)(4).

Manufacturer Narrative

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 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 notifications 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.Locating badges can be used for alarm suppression associated with the nurse call patient safety feature, which automatically cancels and suppresses alerts based on the caregiver¿s presence in the patient room as well as allows the exit alarm to automatically reset when the caregiver leaves the patient room.Inspection of the system by a hillrom technician found the hall centrack batteries were spent leading to a lag time for the rtsl to identify the nurse¿s location and therefore affecting activation of the patient bed alarms.It is noted the account/customer was responsible for maintaining batteries in the centrack devices.Inspection listed the hillrom nurse call functioning as designed.Centrak is a 3rd party company that provides staff locating (rtls) functionality to nurse call.This functionality (and any dependent features) would be impacted if centrak hardware/software had a failure.However, the core nurse call functionality (tones/lights/audio) have no dependency on rtls.Hillrom terms & conditions document for nurse call with cen trak states the following in regard to maintenance: global monitoring system (¿gms¿): the gms receives continuous maintenance information from every component of the centrak rtls, including every tag, every 10 minutes around the clock.This maintenance data is used to analyze the current and predict the future health of the system as a whole as well as each component.The gms allows centrak to maintain the rtls in a proactive rather than a reactive method.All of the maintenance services described herein are predicated upon end user providing internet access, one direction from the site to centrak remote server is sufficient, so that centrak¿s gms can be populated with sufficient information to monitor the system.Additionally, it is noted, hillrom esa service offering provides a battery maintenance service option to the customer, however it has been confirmed the customer did not sign up for this offering.For this event, the patient sustained a laceration reapproximated with dermabond, concluding a serious injury occurred which was likely caused or contributed by deactivation of the bed alarm.The incident was likely due to use error as the technician noted the centrack batteries were spent, and the facility is responsible for maintaining upkeep of these devices.The nurse call system was inspected and noted to be functioning as designed; however, if centrak hardware/software fails, this directly impacts the nurse call system and would likely cause or contribute to a death or serious injury if it were to recur.Therefore, hillrom is cautiously reporting this event.

• Brand Name: VOALTE PATIENT SAFETY; VOALTE SMART SYNC VOALTE SMART SYNCV
• 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 Key: 16395496
• MDR Text Key: 309742351
• Report Number: 2027454-2023-00014
• Device Sequence Number: 1
• Product Code: KMI
• 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: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 4.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention