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 10/05/2022

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 hrc technician investigated the issue and determined that the event was caused by a system wide software error.Technical services remotely turned off the "update function" in the wave interface which mitigated the issue until a software patch could be implemented.An interruption, due to a malfunction of the patient alarm server, in the receipt of an emergent alert, could result in serious injury or death if the event were to recur and the caregiver was solely relying on receiving the secondary alert via mobile phone notification and not the alert that is generated from the primary monitoring device connected to the patient.Therefore, hillrom is cautiously reporting this event.

Event Description

The customer reported that the grs10 alarm was alarming continuously to voalte phones that they could not cancel which prevented any further alarms or alerts from coming through because the wave clinical system was tied up.The event affected multiple locations across the site.No patient impact or safety issues were reported as a result of product performance.This event was captured under hill-rom complaint ref # (b)(4).Hillrom is submitting one mdr report for this event.

• 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: 15715941
• MDR Text Key: 305051107
• Report Number: 2027454-2022-00022
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2022

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: 10/05/2022
• Initial Date FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1