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 06/03/2015

Event Type  Death  

Event Description

The customer reported that their mx40 device did not alarm and there was a death.It has not been confirmed that the customer alleged that the device contributed to the death.

Manufacturer Narrative

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

Manufacturer Narrative

The customer care solution center representative verified the issue with the customer over the phone.No onsite service was requested and none was provided.The customer waited 9 days before reporting the issue to philips.There is no indication if the device was taken out of service or tested by the customer.The customer indicated that their risk management department had been researching the issue.They only wanted the paperwork associated with the call filled out at this time.The customer did not request on site support.The information from the instructions for use (ifu) was provided to the customer.The ifu states "the mx40 is to be used primarily as a traditional telemetry medical device.It connects to the intellivue information center by way of a wireless network.When the mx40 is connected the intellivue information center, the intellivue information center provides the primary patient monitoring and alarming function.The mx40 does not automatically provide local monitoring or alarming when connected to the information center.The mx40 can provide time-limited local monitoring when it is not connected to the wireless network." the customer reported that their mx40 device did not alarm and there was a death.It has not been confirmed that the device contributed to the death.The customer has not been forthcoming providing any data for review.The customer only requested that pse/psa form submitted at this time.The information available for this report/service event is not sufficient to determine a specific cause.A lack of subsequent report of this same issue for >60 days supports that the problems was resolved.The information provided by the philips personnel/customer is considered as all that is warranted for this issue.The product remains at the customer site.No further investigation or action is warranted.

• 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: wendy chadbourne ; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 4878192
• MDR Text Key: 5866790
• Report Number: 1218950-2015-03355
• 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 Facility,health professional,use
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event 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
• Initial Date Manufacturer Received: 06/12/2015
• Initial Date FDA Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2013
• 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