MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 802.11A/B/G

Model Number 865352

Device Problem Device Alarm System (1012)

Patient Problems Asystole (4442); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2023

Event Type  malfunction  

Event Description

It was reported there was no asystole alarm for a patient with an external pacemaker.The mx40 generated a missed beat alarm, but did not generate an asystole alarm at 4.8 seconds of no rhythm.The patient was transferred to the cardiac care unit.The patient information center ix is reported in mfr1218950-2023-00098.

Manufacturer Narrative

Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

A philips clinical application specialist (cas) went to the customer site.The cas obtained the requested logs and provided the patient strip.A philips product support engineer (pse) reviewed the logs and patient strip.The pse concluded that the mx40 patient wearable monitor functioning as designed.The strip provided displays that a missed beat occurred at 01:15:44, because a beat was not detected where the algorithm expected a beat to be; subsequently the algorithm classified 2 p-waves as questionable beats.Based on the information available, the mx40 patient wearable monitor functioning as designed.

Event Description

Based on the information received, the patient was constantly monitored from the piic and the nurse was immediately notified of the alarm "pm not pacing" and was sent to check on the patient.There was no delay in care and no harm to the patient.In addition, per the product support engineer, the criteria for an asystole alarm was not met.The patient was transferred from general cardiac ward to cardiac care unit.The patient information center ix is reported in mfr 1218950-2023-00098.

• Brand Name: INTELLIVUE MX40 802.11A/B/G
• Type of Device: INTELLIVUE MX40 802.11A/B/G
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16411741
• MDR Text Key: 309950466
• Report Number: 1218950-2023-00097
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838030350
• UDI-Public: 00884838030350
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865352
• Device Catalogue Number: 865352
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2019
• 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
• Treatment: TINED LEAD, MODEL 1201
• Patient Outcome(s): Required Intervention