MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING

Model Number 865350

Device Problem Component Missing (2306)

Patient Problem Death (1802)

Event Date 11/13/2017

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported that alarms were not provided for a patient monitored via an mx40 telemetry device and the patient subsequently died.Since the device was in use and staff were not aware of the patient alarms, the device may have been a factor in a delay of response to the patient.The patient expired.

Manufacturer Narrative

The customer did not wish to provide any additional information regarding this case when additional questions were asked by philips.Per communications with the biomedical engineer, the nursing staff did not record or report an incident with the device causing the patient event.The customer originally requested assistance from philips to export the clinical log on the telemetry device.Once the customer realized that the issue was on the pic (patient information center) classic and they could not export the audit log as with the pic ix they did not request a full investigation as again, the customer stated it was not reported as an incident caused by a philips device, therefore no additional information was required by philips.We will not consider a philips device a factor in the patient death.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7082082
• MDR Text Key: 93690891
• Report Number: 1218950-2017-08128
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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