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

Model Number 865352

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer alleges that the mx40 did not give an alarm for a patient condition change and the patient was found by the nurses lying on the floor.There was no patient injury or death reported.

Event Description

In this case the customer alleges that the mx40 did not give an alarm for a patient condition change and the patient was found by the nurses lying on the floor.The patient died.

Manufacturer Narrative

Good faith effort has been made for product return.The device has not yet been received for evaluation and therefore, the cause of this specific case cannot be confirmed at this time.The biomedical engineer advised that the issue was an electrical activity of the heart without any pulse.The nurses at the hospital advised it was not an issue of the mx40, but more of a physiological borderline case.The root cause of the allegation of failure to alarm is unknown due to insufficient information.This event is considered reportable for the allegation of failure to alarm.The device was requested to bench repair, but has not been received for evaluation as of (b)(6) 2019.In the event that the device is returned, the record shall be reopened for further evaluation.Based on the reasonable conclusion of the qualified medical professional from the hospital, the device did not cause or contribute to the event.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.

Manufacturer Narrative

The actual device was returned to philips bench where the technician found no fault that would impact the patient event.The device was scrapped due to having obsolete hardware, firmware, parts, and revision.

• 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
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8732532
• MDR Text Key: 149154232
• Report Number: 1218950-2019-04590
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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