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

Model Number	3.6
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	02/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer contacted hillrom to report a fall event and requested a nurse call report.The customer reported that a patient fell three weeks prior to notifying hillrom, and that at the time of the event, the bed exit call did not the annunciate at the console or at the dome light causing a delay in response.The patient sustained an unspecified fracture which required surgical intervention.It is noted that the patient has recovered and is currently in ongoing rehab.This incident was captured under hillrom complaint ref # (b)(4).
Additional Manufacturer Narrative
The nurse call system provides visual and/or audible event alert notification via designated communication devices (main console, dome light, mobile phone).A bed¿s exit alert feature provides an audible and visual alert notification if the patient is attempting to exit the bed.This alert will enunciate at the bed as the primary notification.The bed can also be used in conjunction with a nurse call system, through the use of a communication cable, to route to and enunciate the alert at designated communication devices.An investigation of the log files show that a successful bed exit call was placed (corresponding to the customer's reported time of the event), the call was acknowledged, and silenced 20 seconds later.In this event, the reported fall resulting in a fracture which required surgical intervention to preclude permanent impairment of body function or damage to body structure, which indicates a serious injury occurred.The nurse call system worked as intended and provided appropriate notification as evidenced by the log files, however, use error cannot be ruled out due to noted acknowledgement and silencing of the call.Therefore for the reasons listed above, 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: 16655232
• Report Number: 2027454-2023-00025
• Device Sequence Number: 12202399
• Product Code: KMI
• UDI-Device Identifier: 00887761001541
• UDI-Public: 00887761001541
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 3.6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/31/2023
• 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