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

Model Number 865350

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 06/25/2015

Event Type  Death  

Event Description

The customer reported that they received a "choppy" waveform on the central station for some time before a patient expired.

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.The customer care solution center representative dispatched a field service engineer, on site to troubleshoot the cause of the issue, as well as test the device in question and obtain logs from the central station.The sequence of events was provided by a philips clinical specialist who worked with the customer remotely regarding this issue.The patient was a known patient at the hospital who was admitted to the orthopedic floor (5th floor) and placed on an mx40 device (room 502) connected to a pic ix central station.The patient was transported for a ct scan via wheelchair, still on the mx40 device.The patient returned from ct scan when the monitor technician indicated that they could not assign the mx40 device to a sector at the pic ix.The customer placed the patient on another mx40 device and assigned it to room #348 (which was monitoring another patient) on a classic pic system but didn't admit the patient.The patient suffered a seizure, coded and was then transferred to the icu.When the cs attempted to find the information in the system, she was unable to find the patient listed in the history.There were no strips available for this event.She confirmed that the patient was discharged without saving the data.The mx40 devices have both been put back into service, without testing of the devices.Logs were sent to a sw engineer, who could not confirm any disconnects during the timeframe in question.He did notice that some devices were having issues connecting to the central station between 2pm and 8pm and the device associated with room 502 had more disconnections that some of the other devices.Onsite evaluation of signal strength for the device in use with room 502 found the signal strength was within specification without any indications of a signal problem.The customer reported that they received a "choppy" waveform on the central station for some time before a patient monitored on an mx40 expired.The customer informed the field service engineer, that the involved devices in question were returned to service immediately after the incident.No reproducible problem with signal strength was identified during onsite evaluation of the original mx40 device.Logs were inconclusive regarding any connectivity problems and did not contain all required information for a complete evaluation of the event as the patient was not admitted at the 2nd information center device.The information available for this report/service event is not sufficient to determine a specific cause.

Event Description

The customer reported that they received a "choppy" waveform on the central station for some time before a patient monitored on an mx40 expired.A patient coded, was transferred to the icu and then later expired.

• 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: 4908900
• MDR Text Key: 15594426
• Report Number: 1218950-2015-03681
• 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: User Facility,user facility
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date: 06/25/2015

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 07/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2015
• 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