MAUDE Adverse Event Report: HILL-ROM CARY VOALTE NURSE CALL; SYSTEM, COMMUNICATION, POWERED

Model Number 4.0

Device Problem Device Alarm System (1012)

Patient Problem Fall (1848)

Event Date 04/07/2023

Event Type  malfunction  

Manufacturer Narrative

Follow up information from the customer¿s biomed representative indicated the beds are not appearing as connected to the system in smartclient and appear as ¿unavailable¿ in the nurse call system.It was also reported that the patient was injured; however, details of the injury were not provided by the customer.The nursing unit where the fall was reported to have occurred was contacted.The nursing staff was unaware of this event and could not provide additional information.The voalte nurse call system provides a comprehensive communication and information system that places patient calls, staff calls as well as emergency and code calls.The system offers several calling options depending on the configuration of the facility.Troubleshooting activities performed by hillrom found the bed in room 824 at the time of the investigation was a progressa bed.A review of the nurse call log file (chronos report) found on (b)(6) 2023, a bed exit alert call was placed at 02:32 and cancelled a minute later.This occurred again at 02:41 and 02:49.No issue was found with bed data or alerts going to the nurse call status board while the technician was onsite to investigate the reported issue.In this event, there was an allegation of a patient fall with injury; however, nursing staff was unaware of the reported event and no additional information could be provided.Based on the limited details provided, there is no indication that a serious injury occurred.Based on a review of the log files and results of the onsite investigation, the nurse call system functioned properly.No malfunction of the system was identified however it can not be ruled out at this time.Additionally, the report indicates the bed exit alert call was acknowledged and cancelled, therefore, use error cannot be excluded for this event.

Event Description

The customer reported the bed exit alarmed but did not annunciate at the nurse¿s station and a patient fell.The event was reported to have occurred on (b)(6) 2023 in room 824 at 02:30.It was initially reported the patient was not injured.Additionally, the customer reported approximately four rooms on the unit where the event occurred that are not showing up on the bed status board or sending bed exit alerts through the nurse call system despite being plugged into the system.This event was captured under hillrom complaint ref # (b)(4).

• Brand Name: VOALTE NURSE CALL
• Type of Device: SYSTEM, COMMUNICATION, POWERED
• 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: 16874846
• MDR Text Key: 314621349
• Report Number: 2027454-2023-00038
• Device Sequence Number: 1
• Product Code: ILQ
• UDI-Device Identifier: 00887761995079
• UDI-Public: 00887761995079
• 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: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4.0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1