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

Model Number 865350

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Cardiac Arrest (1762); Death (1802); Dyspnea (1816); Renal Disease, End Stage (2039); Loss Of Pulse (2562)

Event Date 08/14/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

The patient coded and subsequently expired.It was reported that the patient coded at 11:40 on (b)(6) 2018 and could not be revived.The customer reported that the (b)(6) male patient was admitted on (b)(6) for shortness of breath and end stage renal (chronic kidney) disease from (b)(6) community hospital on (b)(6).The patient returned from an ir thoracentesis (fluid removal).It was confirmed that staff were present when the patient became unresponsive (2 msts and another rn) and were at the bedside when the pulse oximetry monitor alarmed and the patient went unresponsive.The staff immediately activated the code system.The patient went into pea (pulseless electrical activity) and expired after transfer to the icu.The use of the device may have been a factor in the death.

Manufacturer Narrative

Per the philips fse (field service engineer) the telemetry device was tested and was found to be functioning normally and as expected.Strips had been printed for yellow and red alarms per normal operation.The piic ix was tested and was also found to be functioning normally.According to the clinical audit logs at 11:04:36 the patient at (b)(4) was transferred to (b)(4).The equipment (b)(4) was added to the patient at 11:07:40.At 11:07:44 the (b)(4) equipment was online and all alarms resumed at 11:07:49.At 11:14:00 the (b)(4) patient was discharged and the bed was cleared from monitoring.The logs verify that the patient had been discharged and that no central station monitoring was being performed.There was no data to support a philips device malfunction.It was reported that a patient coded at 11:40 on (b)(4) 2018 and could not be revived.Staff was present when the patient event occurred and there was no reported delay in treatment for the event.The biomedical engineering manager stated that there was no allegation that any philips device caused or contributed to the adverse event.He said that there was only a misunderstanding of why some retrospective patient data was missing.The biomedical engineering manager stated that upon investigation by the staff it was determined that the patient had been transferred to dialysis and had been mistakenly discharged.This was verified by the piic ix clinical audit logs.Per the information provided there is no data to support a philips device malfunction.

• 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: 7874122
• MDR Text Key: 120189356
• Report Number: 1218950-2018-07347
• 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: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• 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
• Date Manufacturer Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2015
• 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
• Patient Age: 82 YR
• Patient Weight: 131