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 04/30/2022

Event Type  malfunction  

Event Description

Complaint narrative: a site representative reported that a code blue alarm for (b)(6), a private room, would not clear from the amplion care traffic control (ctc) console clinical dashboard at the nurse's station.The site representative stated there were no patients in the room.Complaint troubleshooting: amplion support contacted the site representative and initiated troubleshooting within 13 minutes of the complaint submission.Amplion support reviewed the smart room controller (src) logs for (b)(6), which indicated an ongoing active code blue alarm from the patient station (pas) in (b)(6).Amplion support asked the site representative to press the code blue button on the pas in (b)(6).Amplion support did not see any src log changes when the site representative pushed the code blue button on the pas, indicating a likely keypad failure.Complaint resolution: amplion support requested the pas be replaced.The site representative stated she would update the house supervisor.Amplion support received a second complaint for the same issue from a separate site representative several hours later, as the device had not yet been replaced.Amplion support reviewed the state of (b)(6) with the second site representative, a care traffic controller (ctc), and reiterated the need to replace the pas due to keypad failure.A site representative indicated that they would reach out to maintenance to have the pas replaced.On 05/02/2022, amplion support spoke with a site representative who stated that he had replaced the pas and confirmed that the code blue was now working.Failure analysis: the returned pas was submitted to failure analysis (fa) testing and failed.Fa testing indicated damaged (burnt/shorted) leads/traces in the flat flexible cable (ffc) with total keypad failure.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 device 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: 17686652
• MDR Text Key: 322711592
• Report Number: 3009164985-2023-00014
• 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: 05/10/2022
• Date Manufacturer Received: 04/30/2022
• 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