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

Model Number P2599NNCINSTALL

Device Problem False Alarm (1013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2021

Event Type  malfunction  

Manufacturer Narrative

Customer reported multiple rooms kept sending code blue alerts on the 2nd floor of the or building.No patient impact or safety issues reported.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 provides annunciation of these calls at both room locations and primary (dedicated) nurse call stations.The voalte® nurse call system also has an option for secondary notifications calls to customer provided third party products (e.G.Cell phones) where calls may also be forwarded.The secondary notification workflows are options offered to the facilities that the facility may or may not choose to implement as an add on to their primary notifications, depending on their facility¿s design and needs.A false code blue alert is not likely to cause or contribute to death or serious injury, if the event were to recur.However, at this time it is unknown, with the information available, if there was another failure of the hillrom device that is likely to cause or contribute to death or serious injury.Therefore, based on a retrospective review of complaints, hillrom is cautiously reporting this event.The complaint investigation is ongoing.Follow up information regarding the investigation and root cause will be provided in a final report.

Event Description

Hillrom received a report that multiple rooms kept sending code blue alerts.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Event Description

Hillrom received a report that multiple rooms kept sending code blue alerts.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

Customer reported multiple rooms kept sending code blue alerts on the 2nd floor of the or building.No patient impact or safety issues reported.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 provides annunciation of these calls at both room locations and primary (dedicated) nurse call stations.The voalte® nurse call system also has an option for secondary notifications calls to customer provided third party products (e.G.Cell phones) where calls may also be forwarded.The secondary notification workflows are options offered to the facilities that the facility may or may not choose to implement as an add on to their primary notifications, depending on their facility¿s design and needs.A false code blue alert is not likely to cause or contribute to death or serious injury.This issue would make the end user aware as the device would be falsely or continuously alarming, bringing the caregiver to the patient and if necessary move the patient to another bed and contact their facility-authorized maintenance person to send the bed for service/repair.Additionally a code call stuck does not impact or prevent other calls from being sent.This issue would be unlikely to cause or contribute to a death or serious injury if it were to recur.

• Brand Name: NURSE CALL INSTALLATION
• Type of Device: SYSTEM, COMMUNICATION, POWERED
• Manufacturer (Section D): HILL-ROM CARY; 1225 crescent green dr., suite 300; cary NC 27518
• Manufacturer Contact: frances coote ; 1225 crescent green dr., suite 300; cary, NC 27518 ; 8129310130
• MDR Report Key: 15253966
• MDR Text Key: 305503105
• Report Number: 2027454-2022-00009
• Device Sequence Number: 1
• Product Code: ILQ
• UDI-Device Identifier: 00887761985209
• UDI-Public: 00887761985209
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P2599NNCINSTALL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• 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