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

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	02/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Voalte nurse call system provides visual and/or audible event alert notification via designated communication devices (mobile phones).The voalte system can be used in conjunction with a compatible nurse call system to relay alerts from said nurse call system to voalte communication devices.The pathway for the alerts notification is as follows: rauland nurse call device (source) sends out patient alarms to hillrom excel system (middleware) to forward to hillrom voalte system/ user phones (destination).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 routing of an alert is configured at application setup based on the customer-provided call type name.Any change in the naming convention of the source would prevent an alert from following its configured pathway unless the new named source was updated in the program configuration by hillrom.Troubleshooting activities determined that the customer changed the source name without notifying hillrom.This name change, on the third-party rauland device (source), disrupted the pathway and prevented the alert from being sent to the voalte phones.Additionally, hillrom technical support determined that the original customer designated call type/name ¿delivery emergency¿ was working properly.In this event, no injury occurred, and there was no malfunction of the voalte system device.This event is contributed to use error of the customer not notifying hillrom of the call source name change.The name was corrected/updated to resolve the issue.Although the alert from the source would display locally at the site of initiation (and other designated areas), the absence of the call routing to mobile phones is likely to result in a delay in emergent care, serious injury or death.Therefore hillrom is cautiously reporting this event.
Event or Problem Description
The customer reported that the "ob emergency" alert did not route from the facilities rauland nurse call system (third-party) to the voalte device (phone).There was no injury associated with this event.This event was captured under hillrom complaint ref # (b)(4).

• Brand Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Common Device Name: 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: 16466139
• Report Number: 2027454-2023-00017
• Device Sequence Number: 7482227
• Product Code: MWI
• UDI-Device Identifier: 00856128007007
• UDI-Public: 00856128007007
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2023

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: 02/10/2023
• Initial Report FDA Received Date: 03/02/2023
• 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