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 07/08/2021

Event Type  malfunction  

Event Description

Complaint narrative: the hospital site representative reported the stat assist alarm would not clear.The stat assist alarm is located on the patient station (pas), which is physically located on the headwall in the patient room.The site representative reported the stat assist alarm was on for an extended period of time.Site personnel later stated that there were no patients assigned to the room at the time of the event and they were not sure how the alarm was triggered.Complaint troubleshooting: prior to initiating troubleshooting, amplion support reviewed the activity logs for the nurse call system smart room controller (src), which is an embedded computer-based device, that controls nurse call devices in a patient room.Amplion support noted a significant amount of activity for both beds in the room.The charge nurse pressed the stat assist button once on both beds to activate the alarms, and then pressed once again on each station to clear the alarms.Src logs showed a button press to activate and another button press to clear the alarm for one bed and no activity for the other.The site representative confirmed patients were not assigned in the room for either bed.Amplion support contacted the site maintenance representative via email providing a description of the issue and requesting further assistance with testing/troubleshooting.During this time, amplion support received additional complaints from different site representatives that the smart light, outside the patient room, above the door was "stuck in red." amplion support worked with one of the representatives to clear the light, however the light automatically re-activated.Amplion support again contacted the site maintenance representative for assistance with testing/troubleshooting.Testing showed no activity in the src logs for 206-a, and activity as expected for 206-b.206-b indicated full functionality.Complaint resolution: amplion support recommended replacement of the pas for the affected unit.Src logs indicated the affected unit had been replaced and both the stat assist and code blue button had been tested with full functionality.Failure analysis: due to the time that has elapsed since this complaint was resolved, amplion does not anticipate receiving the product.Therefore, no failure analysis can be conducted to determine the specificity of the failure and possible reasons.

• 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: 17653559
• MDR Text Key: 322321032
• Report Number: 3009164985-2023-00006
• 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: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2021
• 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