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 Type  malfunction  

Event Description

This report summarizes 9 malfunction events.Complaint narrative.Amplion support received a complaint on 07/06/2022 from a site representative, the respiratory therapy manager, at a single site; she reported that the stat assist button on the patient station (pas) was non-responsive for 6 beds.Rooms/beds reported included 731-a (semi-private room), 731-b (semi-private room), 732-b (semi-private room), 740 (private room), 744 (private room), and 748-b (semi-private room).Note: bed 748-b was previously reported within a separate complaint.At the time of that complaint, it was believed to be a stand-alone event and was addressed accordingly.It will not be further addressed here.Site representatives did not report this complaint to be associated with a patient-related event.Complaint troubleshooting note: troubleshooting related to the events described in this report occurred over the course of several days.Amplion support requested that the site representative go into one of the reported rooms and press the stat assist button on the pas; the site representative pressed the stat assist button in room 744.Smart room controller (src) logs, which display system activity from the device, showed no activation within the system related to this button press.(note: the src is an embedded computer-based devices that controls nurse call devices in a patient room).Amplion support power-cycled the src remotely (i.E., turned the src off and then back on) and asked the site representative to press the stat assist button again, which again showed no activity.Amplion support requested the pas be replaced.Amplion support continued to work with the site representative to assess the remainder of the reported rooms.No src log activity was noted on the reported rooms.Amplion support verified system functionality for the stat assist by having the site representative press the stat assist button on a pas in a room believed to be functional.The stat assist activated per design when pressed on this pas, indicating that the failures in the other rooms were likely isolated to the individual devices and not representative of a system-wide failure.The site representative then reported that the leds associated with the buttons on the pas were not illuminated on the devices in the reported rooms.Upon learning that leds not illuminated would indicate a failure of some sort, the site representative indicated she would check the devices in additional rooms and identify any additional pas devices that did not have illuminated leds.In follow-up troubleshooting, the site representative was asked to coordinate with amplion support to test the code blue on the pas devices in rooms 740 and 744; the src logs did not show activity related to the code blue button press in either room.Amplion support contacted the regional it representative for the site, who is the designated contact for the site.The regional it representative coordinated with amplion support to test and replace one of the reported pas devices.Room 731 was selected and both pas devices in this room were tested; neither device showed src log activity for the either the stat assist or code blue buttons.The regional it representative replaced the pas for bed 731-a and the pas for 731-b.He reported that both replacement pas devices had illuminated leds and activated alarms for both the stat assist and code blue.Amplion support confirmed src log activity for both beds.The regional it representative also replaced the pas in room 740 and verified stat assist and code blue functionality.Based upon the findings of additional potential failures by the initial site representative during her cursory audit, amplion support, in coordination with the site's administration, provided additional remote support to further assess the pas devices for all beds/rooms on the impacted unit.This additional assessment and the resolution steps taken are discussed further in the additional manufacturer narrative provided in h10.

Manufacturer Narrative

In summary amplion support received a complaint reporting patient station (pas) stat assist button failure for 6 devices.(3) pas devices were tested on-site and replaced.(2) pas devices were tested on-site and not replaced by site representatives.(1) pas device was addressed in a separate complaint and investigation.Amplion provided remote support to assess the hospital's 51 beds for pas functionality in follow-up to an independent audit conducted by the site representative.Testing of each pas included: code blue button press, stat assist button press, nurse call activation and cancellation, bed status button press, and led illumination.A total of 9 out of 51 pas devices tested experienced a keypad-related failure, failing to activate the code blue alarm; this is an mdr reportable failure.Malfunction events summarized in this report: 9.Devices returned to amplion: 3.Devices labeled "for single use": 0.Devices reprocessed and reused: 0.Failure analysis.Of the 9 failed pas devices, amplion received and conducted failure analysis (fa) on 3 pas devices returned from the site.Failure analysis of the 3 devices returned indicates consistent physical damage to the device keypad originating from an external source.The failure analysis testing process revealed extensive damage to the flat flexible cable (ffc) traces; 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 (e.G., spraying cleaning chemicals directly onto surfaces), resulting in liquids/cleaning agents getting under the device's keypad overlay.Individual device information is provided below for the 3 devices returned to amplion and failure analysis forms are attached for reference.Returned device 1.Model number: d-pas-12-1.Catalog number: d-pas-12-1.Serial number: (b)(6).Lot number po 7457 ps012 121016.Udi: n/a.Manufacture date: 01/18/2017.Returned to amplion: 07/15/2022.Returned device 2 model number: d-pas-12-1 catalog number: d-pas-12-1 serial number: (b)(6).Lot number po 7457 ps012 121016.Udi: n/a.Manufacture date: 01/18/2017.Returned to amplion: 07/15/2022.Returned device 3.Model number: d-pas-12-1.Catalog number: d-pas-12-1.Serial number: (b)(6).Lot number po 7457 ps012 121016.Udi: n/a.Manufacture date: 01/18/2017.Returned to amplion: 07/15/2022.Regarding additional failed devices.Based upon review of the site's profile, amplion was able to determine that all pas devices installed at this site prior to the date of this complaint, and thus all devices involved in this complaint investigation, were model/catalog number d-pas-12-1.Amplion is unable to provide serial numbers for the additional failed devices.Devices manufactured during the time period associated with these products do not include identifying information on external labeling; serial numbers are located inside the device casing and are inaccessible without removal of the device from the wall.Amplion support generally obtains serial number information for such devices once all troubleshooting has been completed and it has been determined that the device must be replaced.This prevents introduction of the risk that the device will be physically altered, possibly skewing troubleshooting and findings, or causing further damage to the device.Because the additional failed devices were not replaced (see conclusion below) or returned, amplion was unable to obtain serial numbers or other more specific identifying information.Conclusion: the failed devices are no longer installed at ssh - cleveland gateway.To amplion's knowledge, the site did not replace the remaining failed devices identified during troubleshooting and on-site testing, as the site was already scheduled for uninstallation and decommission of the amplion system related to this complaint.As part of amplion's change in strategic direction and initiative towards removal of its nurse call system from all customer sites, all amplion devices were uninstalled at ssh - cleveland gateway, as scheduled, beginning 08/01/2022 and the amplion system at this site was decommissioned on 09/06/2023.

• 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: 17759527
• MDR Text Key: 323543439
• Report Number: 3009164985-2023-00018
• Device Sequence Number: 1
• Product Code: IQA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 9
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: D-PAS-12-1
• Device Catalogue Number: D-PAS-12-1
• Device Lot Number: PO 7457 PS012 121016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1