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 03/27/2022

Event Type  malfunction  

Event Description

Complaint narrative: the corporate help desk representative for the site submitted a complaint stating that the site was reporting the amplion nurse call system was ringing nonstop from the first floor to the second floor of the facility.Complaint troubleshooting: during their initial call with an onsite representative, approximately 30 minutes after the compliant was submitted, the onsite representative told amplion support that there was a stat assist active in (b)(6) and that there was no longer a patient in the room.Amplion support confirmed via smart room controller (src) logs that the patient station (pas) in (b)(6) was repeatedly and sporadically activating and then clearing the stat assist alarm.Based upon what was communicated by the site representative, these alarms appear to have been initiated by the device itself; occuring without interaction between site personnel and the device.Amplion support determined the active alarm was the cause of the system alarming throughout the facility.Amplion support began troubleshooting the (b)(6) pas with the site representative.Amplion support asked the site representative to press the stat assist button on the pas once.The site representative asked another staff member to press the stat assist button, but did not relay the specific directions to 'press the button once'.Amplion support asked the site representative to press the stat assist button again.Amplion support did not see log activity for the pas in (b)(6), indicating a likely failure of the device.When asked, the site representative reported leds flashing on the pas for both the stat assist and the code blue buttons.Src logs did not reflect this activity.While troubleshooting a second complaint for (b)(6) (involving an src room fault in the room), amplion support again performed troubleshooting on the (b)(6) pas with another site representative.Amplion support was able to clear the fault.All devices in the room were recognized by the src except for the bed input station (bis), which was addressed separately from this complaint.Amplion support asked the site representative to test the stat assist and code blue buttons on the pas.Src logs did not reflect any activity.The site representative stated there were no lights illuminated on the pas.The site representative confirmed that the ribbon cable (which connects the pas keypad to power and communication capabilities) appeared to be connected, therefore was not the cause of the lack of lights on the pas.Complaint resolution: amplion support recommended replacement of the pas.The site representative replaced the pas.Amplion support worked with the site representative to verify functionality, confirming that both the stat assist and code blue alarms were activated and cleared as expected on the replacement device.Failure analysis: the returned pas was submitted to failure analysis (fa) testing and failed.Fa testing indicated damaged (burnt/shorted out) of all leads/traces in the flat flexible cable (ffc).Damage to the traces of the ffc can cause loss of functionality to one or more keypad buttons or leds.This damage is often caused by improper cleaning practices, resulting in liquids/cleaning agents getting under the devices keypad overlay.

• 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 ; 6155779000
• MDR Report Key: 17686250
• MDR Text Key: 322712461
• Report Number: 3009164985-2023-00013
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: D-PAS-12-1
• Device Catalogue Number: D-PAS-12-1
• Device Lot Number: PO 6802 PS04B 012516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Date Manufacturer Received: 03/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2016
• 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