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 01/20/2023

Event Type  malfunction  

Manufacturer Narrative

The nurse call system is a comprehensive communication and information management system that helps caregivers provide the best possible care to patients in the most efficient manner.The system facilitates communication within a nursing unit.Caregivers have the ability to quickly locate and communicate with a fellow staff member, and patients can easily communicate with caregivers, the nursing station, or directly to their primary caregiver.When a bed is used in conjunction with voalte nurse call, the bed¿s exit alert notification, in addition to alerting at the bedside, is routed to designated communication devices (nurse console, patient station, dome light, mobile phone, etc.) and provides a visual and/or audible event alert notification at the designated device.The voalte nurse call instructions for use notes ¿the nurse call system is designed to be used only as a secondary alarm system for bed exit alarms.It should never be used as the primary bed exit alarm system.Troubleshooting into the reported event determined that the customer was not able to see any alarms coming from nurse call in alarm notification because of a configuration change to a new unit that had happened the day before the issue was reported.It was additionally determined the alerts were still working without issue on the voalte mobiles.A configuration change in the database resolved the issue.If nurse call alarms not alerting at the nurses station were to recur, it would be likely to cause or contribute to serious injury or death.Therefore hillrom is cautiously reporting this event.

Event Description

The customer reported that alarms coming from nurse call were not visible in alarm notification.There was no report of patient injury or delay in care.This event was captured under hillrom 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: 16377794
• MDR Text Key: 309551428
• Report Number: 2027454-2023-00008
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2023

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
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1