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

Model Number 865352

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported that a patient underwent unnecessary treatments when the 12-lead ecg print out was interpreted by doctors as a result of the mx40 ecg being changed to from standard lead placement to easi.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

The customer reported that a patient was administered immediate intervention based on the mx40 ecg output.The customer reported that the easi is seen on the monitor and on the printout of the ecg, however the patient was still rushed to the angiography suite for an intervention.The actual device was not returned for evaluation.However, a philips product support engineer (pse) provided the following: the factory default setting is for standard lead placement/analysis and the selection for easi derived ecg analysis cannot be disabled.Based on our investigation, in these cases the lead configuration setting had been changed to easi lead configuration and was not reset to standard after use.The device was performing to specifications.The device was not received for evaluation and are not expected to be returned submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: INTELLIVUE MX40 802.11A/B/G
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10627638
• MDR Text Key: 209835171
• Report Number: 1218950-2020-05845
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865352
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 102