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

Model Number 865352

Device Problems Device Alarm System (1012); Communication or Transmission Problem (2896)

Patient Problem Loss of consciousness (2418)

Event Date 02/24/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported a patient death that occurred on (b)(6) 2019.The nurses found the patient unresponsive between 01:15 and 01:30.It was alleged that the alarm messages were not being forwarded to the central station from the mx40 telemetry device.

Manufacturer Narrative

In a review of the clinical audit logs for (b)(6) 2019 between 00:41:54 and 01:42:42 there were 132 ecg "leads off" technical alerts generated at the central station for this patient.The alarms were silenced 70 times by the users through user interaction with the central station ix device.The field service engineer (fse) gathered the piic ix clinical audit logs and reviewed the data.He stated that the reason why there were no alarms for this patient event was that the green and black iec leads were disconnected from the patient.Thus there was no ecg monitoring.The nurses were alerted to the issue via multiple technical "leads off" alarms annunciated at the central station.The fse stated that the patient details were not allowed to be provided by the site.There is no data to support a device malfunction.

• 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: 8399282
• MDR Text Key: 138113080
• Report Number: 1218950-2019-01825
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838030350
• UDI-Public: (01)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,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2014
• 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