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 09/09/2021

Event Type  malfunction  

Event Description

Complaint narrative: amplion support received a complaint ticket from a site representative responsible for monitoring patient care, who reported the code blue button was not working in room (b)(6), a private patient room.While a patient was assigned to the room at the time of the complaint was initiated, no specfic patient-involved event was reported by site representatives in relation to the complaint.Complaint troubleshooting: amplion support was able to begin troubleshooting with the site within 20 minutes of receiving the complaint.Amplion support restarted software (rex) and the patient station (pas) was 'discovered' successfully by the system.Amplion support requested a site representative go into room (b)(6) and press the code blue button on the pas.A certified nurse assistant (cna) pressed the code blue button in the room.The alarm did not activate nor post to the nurse station console or care traffic control (ctc) console.Smart room controller (src) logs showed no activity/changes in the system.Complaint resolution: amplion support requested the pas be replaced.The site representative was asked if a qualified site representative was available to replace the pas.The site representative committed to investigate the possibility of a maintenance representative replacing the pas.On 09/10/2021, amplion support attempted to contact the materials manager (mm) to replace the pas.The mm did not answer when called by phone and there was no option to leave a voicemail.An email was sent to the mm explaining the issue, troubleshooting completed, and recommendations for pas replacement.On 09/13/2021, amplion support again tried to call the mm and received no response.This was followed by an email to the mm, requesting action on the pas replacement.The mm responded via email requesting information on a potential replacement device.The mm asked for a new pas to be shipped.Amplion support confirmed with a site representative that a patient was assigned to room (b)(6) and recommended to the charge nurse that the patient be independently monitored or removed from the room until the pas could be replaced.The charge nurse was provided an explanation of the current state of the pas and the code blue button.The recommendation was made that the patient should be moved, as patient monitoring was required separate from amplion care assurance.The pas in rooom (b)(6) was replaced and tested for functionality on 09/14/2021.The mm replaced the pas.Testing between amplion support and the mm confirmed the code blue was fully functional.The mm provided amplion support the serial number of the pas that was replaced ((b)(6)).Failure analysis : failure analysis testing of the returned pas indicated that the device experienced keypad failure caused by the flat flexible cable (which provides power and functionality) not being connected to the device's printed circuit board, as designed.While amplion is unable to verify exacly when the flat flexible cable became disconnected, historical analysis indicates that when devices are handled improperly during installation/replacement by user sites, the flat flexible cable can become disconnected.

• 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: 17653576
• MDR Text Key: 322377513
• Report Number: 3009164985-2023-00008
• 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: 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: LOT-PAS12-2021-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Date Manufacturer Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2021
• 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