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

Model Number	NG
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It as reported that the hillrom anesthesia consult button was activated and the operating room control desk phone received the alert but the anesthesiologist was not alerted on the voalte phone or the hill-rom status board in the anesthesia bunker.The site additionally reported that there were no tones or lights outside the room.This event was captured under hillrom complaint ref # (b)(4).
Additional 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 hospitals device monitoring or electronic data management systems.Do not rely on the wave clinical platform product as the sole source of alarms.Troubleshooting into the reported event noted that the nurse call system was not impacted; however, it was determined that a vad was misconfigured resulting in an interruption of the vaam service.The technician worked with the customer to correct the vad.A missed alarm notification, due to a malfunction of vaam, in the receipt of an emergent anaesthesia alert, could result in serious injury or death if the event were to recur.Therefore, hillrom is cautiously reporting this event.

• Brand Name: VOALTE PATIENT SAFETY; VOALTE SMART SYNC VOALTE SMART SYNC
• Common Device Name: 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: 16626703
• Report Number: 2027454-2023-00021
• Device Sequence Number: 17257569
• Product Code: KMI
• UDI-Device Identifier: 00856128007007
• UDI-Public: 00856128007007
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/28/2023

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
• Device Model Number: NG
• 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: 03/01/2023
• Initial Report FDA Received Date: 03/28/2023
• 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