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

Model Number 865350

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Type  Death  

Manufacturer Narrative

Patient information has been requested.Date of event requested.A follow up report will be submitted once the investigation is complete.

Event Description

A patient was taken down from their room to the radiology department.They were on a mx40 tele pack and connected to the piic classic system on their floor.The area around radiology was supposed to be hooked up to the its system during an install but it was not.The hospital was aware of this issue and they were normally taking patients to the radiology area on transport monitors.In this case, the patient was not on a transport and only on a tele box.While in the radiology area, the patient got sick and was taken back up to their floor where they coded and passed.The vitals were then checked to see what happened right before the patient coded and they noticed that the records were not there because the patient had dropped from the its system while they were in radiology.The patients vitals dropped off the nurses station pic classic system due to its not being hooked up in radiology.There was no its connection in radiology.It is unclear whether the absence of monitoring or loss of vitals was a contributing factor in the death of the patient.

Manufacturer Narrative

Multiple attempts were made to reach the risk manager to have information provided about the adverse event.There was no information forthcoming about the patient, any circumstances surrounding the event, about the treatment, or any piic system logs or patient strips.The only information available is from the original problem description from the customer.According to the problem description provided by the customer, the issue seems to have been found when examining the retrospective data of the patient's vitals.There does not appear to be any indication that there was a delay in treatment.With a loss of connectivity to the network, the mx40 would turn on and provide local monitoring and alarming in monitor mode and would alert the caregivers of any change in the patient's condition.Per the customer's description of the event, the staff was aware that when they took a patient to radiology that there would be no central monitoring.According to the customer's description of the event, the change to the patient's condition was observed by the staff and it was deemed appropriate to return the patient to their room where there would have been normal bedside and central station monitoring provided.The patient later coded and expired.Based on the information provided there is no data to support that the mx40 malfunctioned, although use of the mx40 may have been a factor in the adverse event.

• 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: 7464302
• MDR Text Key: 106615601
• Report Number: 1218950-2018-03697
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: (01)00884838082236
• 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: 03/29/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 865350
• Device Catalogue 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: 03/29/2018
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: 03/29/2018
• Supplement Dates FDA Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2017
• 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