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 08/10/2021

Event Type  malfunction  

Event Description

Complaint narrative: amplion support received an email complaint from the hospital's it helpdesk.The ticket was initiated by a hospital representative reporting "the call volume and call light will not come on when pressed in room (b)(6)." amplion support contacted the site and spoke with the telemetry technician, who stated he was not aware of the issue noted, and asked the amplion representative to call back the following morning, stating that the original complainant worked during the day.Amplion support contacted the site the following morning and spoke with the telemetry technician, who recommended amplion support contact the regional it representative, who was onsite.The regional it representative was contacted and stated one of the patient stations (pas) was not working in room (b)(6).When asked, the regional it representative reported there were no leds illuminated on the pas.He stated that the led on the pas that indicates bed status (occupied, out of service, available) was not illuminated.He also stated that when pressing the code blue or stat assist button, there was no response from the pas activating the code blue or stat assist alarm.Site representatives did not communicate any event involving a patient related to the pas failure.Complaint troubleshooting: amplion support remotely restarted the room, and the activity logs for the nurse call system smart room controller (src) indicated all devices 'discovered' in the system.(the src is an embedded computer-based device that controls nurse call devices in a patient room).The regional it representative was asked if the leds illuminated; he replied there were no lights illuminated.Amplion support concluded the issue may be related to a keypad failure.Complaint resolution: amplion support requested the pas be replaced.The regional it representative agreed to replace the pas and committed to calling amplion support when completed.The following day, amplion support called the regional it representative to verify replacement of the pas.The regional it representative stated he was waiting for the patient assigned to room (b)(6) to be moved before he could replace the pas.The regional it representative stated he would contact amplion support when the pas was replaced.Amplion support called the regional it representative on 08/18/2021 regarding the pas replacement and requested a timeline for replacement.The regional it representative reported that he had not replaced the pas and would not until the room was not occupied by a patient, and committed to updated amplion support when the device was replaced.On 08/23/2021, amplion support contacted the regional it representative to verify replacement of the pas.The regional it representative reported that he had not yet replaced the pas because the room was occupied by a patient, and committed to checking the room availability when he returned to the site the following day.On 08/27/2021, amplion support contacted the regional it representative via email with a reminder to replace the pas.On 09/16/2021, amplion support called the regional it representative, who reported that the room remained occupied by a patient and was not replaced.On 09/20/2021, amplion support attempted to contact another site representative, the materials manager (mm), leaving a voice mail.On 09/24/2021, amplon support called the site, and was able to speak directly with the mm.Amplion support requested the pas be replaced for room (b)(6).The mm agreed to replace the pas.On 09/27/2021, amplion support called the mm regarding the pas replacement.The mm stated she did not have a chance to swap out the pas.On 09/28/2021, amplion support called the mm regarding the pas replacement.The mm stated the 'b' side of the room is not used.Site representatives noted a patient was assigned to the 'a' side of the room.Amplion support stated that the pas on the 'b' side of the room was not working, and could impact patient safety.The mm agreed to replace the pas, and to follow up with amplion support when complete.On 09/30/2021, amplion support called the mm regarding the pas replacement.The mm stated that she had not yet replaced the pas and that she would do so when the site decided to use the 'b' side of the room.The mm stated that amplion support could resolve the complaint ticket.Amplion support again re-stated that the 'b' side pas was not working and the status of the pas could impact patient safety if an attempt was made to use the pas.Failure analysis: because site representatives chose not to replace the pas associated with the complaint, the product was not 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 ; 6155779000
• MDR Report Key: 17653573
• MDR Text Key: 322328082
• Report Number: 3009164985-2023-00007
• 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: Other
• Type of Report: Initial
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• 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: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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