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

Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hillrom technician found the vaam was not configured for some new rooms.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 arranged to get the rooms configured 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 or Problem Description
Hillrom received a report stating the nurse call was not routing to wireless devices-call bell system.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: WAVE CLINICAL PLATFORM
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• 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
• MDR Report Key: 17414811
• Report Number: 2027454-2023-00062
• Device Sequence Number: 18386501
• Product Code: MWI
• UDI-Device Identifier: 00856128007007
• UDI-Public: 00856128007007
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2023

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown