MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC MX40 2.4 GHZ SMART HOPPING

Model Number 865351

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 09/13/2022

Event Type  Death  

Manufacturer Narrative

(b)(4) will address issue with mx40 and (b)(4) will address issue with piic.A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported that the telepack mx40 transferred from different zones in picix not done properly by customer resulted in monitor loss.The nursing staff was attempting to monitor patients with mx40 to the central station.While troubleshooting the issue, the patient expired while not being monitored.

Event Description

The customer reported that the telepack mx40 transferred from different zones in picix not done properly by customer resulted in monitor loss.The nursing staff was attempting to monitor patients with mx40 to the central station.While troubleshooting the issue, the patient expired while not being monitored.A good faith effort (gfe) was sent to obtain additional information regarding the issue.Per gfe response, the customer was undergoing a picix rev b to rev c upgrade the day the incident happened; due to the upgrade and downtime caused by the upgrade, the customer biomed team moved 6 mx40s from one unit to another.However, the device transfer was not done properly, and they did not assign a proper rf id code.Also, the biomed did not confirm with the fse and returned the units (mx40s) to the nurses.The nursing team was not able to use and assign the tele packs in the central station and the patient.While the nursing team was troubleshooting the mx40 connection to the central stations the patient incidents occurred.When the fse philips team investigated the problem, it was noted that the mx40 tele packs were not configured to the correct rf access code, and it was confirmed by the customer biomed team that the mistake was made by their own team members.Further, it was stated neither the mx40 or piic contributed to the patient death, but it would be considered a near miss.The nursing team was troubleshooting the connection from the mx40 to the central station when the patient incident occurred.The pic ix device involved in this event is report in mfr number 1218950-2022-00901.

Event Description

The customer during a picix rev b to rev c upgrade, the customer biomed transferred 6 mx40s from 3b-cardiology unit to 3b-icu unit.During the transfer the customer did not match the rf access code in the mx40s with that of the picix, so the device and the its system were in different rf access codes.A philips field service engineer (fse) went to the customer site.The engineer determined that the issue was associated with the customer underdoing a picix rev b to rev c upgrade.The customer biomed team moved 6 mx40s from the 3b-cardiology unit to 3b-icu unit.The devices were not properly assigned a proper rf id code.Also, the biomed did not confirm with the fse and returned the units, mx40s, to the nurses.The nursing team was not able to use and assign the tele packs in the central station and the patient.While the nursing team was troubleshooting the mx40 connection to the central stations the patient incidents occurred.When the fse philips team investigated the problem it was noted that the mx40 tele packs were not configured to the correct rf access code, and it was confirmed by the customer biomed team that the mistake was made by of their team members.The fse confirmed that the mx40 did not contribute to the patient death, and the customer biomed team confirmed that the mistake was made by their team members.The fse also confirmed that the telemetry units were configured to the correct rf access code after the reported incident.The device was in use on a patient at the time of event.There was an adverse event reported; however, the device did not cause or contribute to the event reported.

• Brand Name: MX40 2.4 GHZ SMART HOPPING
• Type of Device: MX40 2.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15520582
• MDR Text Key: 300986261
• Report Number: 1218950-2022-00898
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082243
• UDI-Public: 00884838082243
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865351
• Device Catalogue Number: 865351
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 94 YR
• Patient Sex: Male