MAUDE Adverse Event Report: AMPLION CLINICAL COMMUNICATIONS, INC. AMPLION CARE ASSURANCE; PATIENT STATION

Model Number D-PAS-12-1

Device Problem Key or Button Unresponsive/not Working (4063)

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

Event Date 02/14/2023

Event Type  malfunction  

Event Description

Complaint narrative: the hospital safety officer reported that a nurse pressed the stat assist button on the patient station (pas), located on the headwall in a patient room 2614.The stat assist alarm did not activate when pressed.Smart room controller (src) logs show no indication of stat assist activation at the reported time of event, nor at any other time during the time span of 5:00 am to 12:00 pm ct.The rn who was involved in the event reported that the patient was not breathing, at which time the stat assist button was pressed and did not activate.The rn reported announcing the stat assist from the doorway of the patient room to the unit secretary at the nurse's station.The unit secretary announced the stat assist and a code blue from the nurse's station using the amplion system clinical dashboard.The notification posted to the clinical dashboard, all hallway monitors, and was sent to staff handheld phones.Note: the amplion system provides the option to call an emergency alert (code blue and/or stat assist) from the nurse's station using the non-room code blue and non-room stat assist functionality.The room number is entered into the system when activating.The alert_history_messages table from the messaging database confirmed the non-room stat assist and non-room code blue were activated for room 2614 at 07:48:05 am ct and 07:49:57 am ct.Reporting within the nurse call software further confirms the non-room stat assist and non-room code blue alerts for room 2614 posted to the clinical dashboard at the aforementioned times and were sent to appropriate staff as deemed by hospital leadership.Reporting within the nurse call software confirms that numerous alerts for pulse oximeter alarms in room 2614 were sent to staff within the two hours prior to the emergency alarms, beginning at 05:33:49 am ct.Most notably, pulse oximeter alarms were sent at 07:33:21 am ct and 07:44:19 am ct, just before the emergency alarms were activated at 7:48 am and 7:49 ct.The amplion system provides various methodologies to alert staff regarding the patient's clinical status.These pulse oximeter alarms would have alerted staff to be aware of the apparent declining state of the patient prior to activation of the emergency alarms.At the time of the complaint call, the safety officer reported the patient was stable.Complaint troubleshooting: during the initial complaint call, approximately 1.5 hours after the event, amplion customer support worked with the site's safety officer over the phone to coordinate the testing of the stat assist and code blue buttons on the patient station in room 2614.The safety officer was asked to press the stat assist button.The safety officer reported pressing the stat assist button several times and stated the alarm did not activate.Src logs did not indicate any changes.The safety officer was asked to press the code blue button.The safety officer reported pressing the code blue button several times and stated the alarm did not activate.Src logs did not indicate any changes.When asked, the safety officer reported that the patient station did not have any leds illuminated.Note: the patient station is designed with a persistent illuminated led on the faceplate to indicate the bed status.Normal use of the system includes user interaction with the pas when changing the status of the bed (e.G., occupied, out of service, available); noting the presence or absence of the bed status led during this interaction provides a visual cue to the user as to whether the device is powered and functioning properly.Amplion customer support advised the safety officer that the patient should be moved out of the room if the room could not be addressed immediately.Complaint resolution: amplion customer support requested the failed patient station in room 2614 be replaced.The pas was replaced, and then tested.The stat assist button was pressed.Src logs confirmed the stat assist was pressed and activated at 03:48:42 pm ct, and cleared in the room at 03:48:45 pm ct.Reporting within the nurse call software confirmed that the alert posted to the clinical dashboard and was sent to appropriate staff as deemed by hospital leadership.The code blue button was pressed.Src logs confirmed the code blue button was pressed and activated at 03:48:48 pm ct, and cleared in the room at 03:48:51 pm ct.Reporting within the nurse call software confirmed that the alert posted to the clinical dashboard and was sent to appropriate staff as deemed by hospital leadership.Amplion customer support requested that the failed device be returned to amplion for failure analysis.

• Brand Name: AMPLION CARE ASSURANCE
• Type of Device: PATIENT STATION
• Manufacturer (Section D): AMPLION CLINICAL COMMUNICATIONS, INC.; 632 melrose avenue; nashville TN 37211
• Manufacturer (Section G): AMPLION CLINICAL COMMUNICATIONS, INC.; 632 melrose avenue; nashville TN 37211
• Manufacturer Contact: cathy anderson ; 632 melrose avenue; nashville, TN 37211
• MDR Report Key: 17148111
• MDR Text Key: 317675220
• Report Number: 3009164985-2023-00005
• Device Sequence Number: 1
• Product Code: IQA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/16/2023

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 Operator: Health Professional
• Device Model Number: D-PAS-12-1
• Device Catalogue Number: D-PAS-12-1
• Device Lot Number: PO 7647 PS012 121016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• Initial Date Manufacturer Received: 02/24/2023
• Initial Date FDA Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1