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

Model Number 865350

Device Problem Device Alarm System (1012)

Patient Problem Death (1802)

Event Date 03/03/2017

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted after philips obtains more information concerning this event.

Event Description

The customer reported that someone died while monitored on a mx40 telemetry device.There was no further information initially provided.Follow-up phone contact with the risk manager, found that the customer alleged that the device did not alarm for over an hour to alert staff of the patient's condition.An investigation is needed to ascertain whether the device caused or contributed to the adverse patient event.

Manufacturer Narrative

The cause for the failure to alarm cannot be determined with the information provided as the piic audit log and mx40 device log data were incomplete and patient strips were not provided.There was insufficient data provided to determine whether the battery tray adapter or battery contact contamination played a role in the adverse event.The battery adapter tray was discarded at the bench and the device was updated at the bench with new hardware and software and returned to the customer some weeks before the adverse patient event was reported to philips.The piic audit logs and mx40 device logs only show that there were intermittent reboots and intermittent ecg leads off alarms up to 02:49 but nothing happened that was log audited after that other than an annotation on a saved strip at 3:10.Between 3:10 and 7:20 there is nothing being log audited for this device.There was no further detail from the mx40 device logs.Use of the device is considered to be a factor as the customer said the staff was not aware of alarms, however insufficient information was provided to make a determination as to the probable cause.The cause of the issue is unknown based on the information provided.

• 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: denyse murphy ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6452697
• MDR Text Key: 71461719
• Report Number: 1218950-2017-02096
• 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: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 865350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/03/2017
• Supplement Dates Manufacturer Received: 03/21/2017
• Supplement Dates FDA Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2013
• 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