MAUDE Adverse Event Report: HILL-ROM CARY MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS); WAVE CLINICAL PLATFORM

Model Number NG

Device Problem Device Alarm System (1012)

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

Event Date 10/06/2022

Event Type  malfunction  

Manufacturer Narrative

The wave clinical platform is software intended to route, store, and display data, alarms, results and diagnostic information from medical devices, electronic medical records (emr), and clinical information systems (cis).The wave clinical platform is a remote monitoring platform that displays physiologic data, waveforms, alarms, results and diagnostic information routed through the platform from supported devices and systems.The wave clinical platform is intended for use in hospital or hospital type environments.The wave clinical platform is intended to be used by healthcare professionals for the following purposes: to remotely consult regarding patients¿ statuses; to remotely review other standard or critical near real-time patient data, waveforms, alarms, and results in order to utilize this information to aid in clinical decisions.The user manual contains warnings such as "the wave clinical platform is intended to supplement and not replace any part of the hospital's device monitoring or electronic data management systems.Do not rely on the wave clinical platform product as the sole source of alarms".The hillrom voalte mobile system provides visual and/or audible event alert notification via designated communication devices (mobile phones).Notification calls are configured with naming convention, audio and /or visual displays based on customer preference at the time of initial integration.The device instructions for use state, ¿the external relay is designed to be used only as a secondary notification system.It should never be used as the primary means of notification.¿ the report notes rooms 450-459 never received alarms as they were not configured correctly.The cause of the incorrect configuration is unknown.After the event, changes were made in bed maintenance enabling routes for the rooms, and they were then able to see alarms in vaam.Bed maintenance is the backend for bed master and hillrom makes any unit/bed configurations.It is reported the system was functioning as designed post the reconfiguration.There was no injury or alleged delay reported from the event; however, a missed code blue alert would likely cause or contribute to a death or serious injury if it were to recur.Therefore, hillrom is cautiously reporting this event.

Event Description

It was reported that a patient code blue asystole event did not annunciate an alert to the voalte mobile phone, nor did it show up within the server.The customer confirmed no patient injury occurred as a result of this event.This event was captured under hill-rom complaint ref # (b)(4).

• Brand Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Type of Device: WAVE CLINICAL PLATFORM
• 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: 15734786
• MDR Text Key: 307564506
• Report Number: 2027454-2022-00024
• Device Sequence Number: 1
• Product Code: MWI
• UDI-Device Identifier: 00856128007007
• UDI-Public: 00856128007007
• 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: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: NG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1