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

Model Number 865350

Device Problem No Device Output (1435)

Patient Problem Death (1802)

Event Date 10/28/2019

Event Type  Death  

Manufacturer Narrative

Pt id and event info have been requested, not available at time of report.A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported on (b)(6) 2019 after generator test, patient in tele 6936 has no data from tele and the patient expired.Further information has been requested.

Manufacturer Narrative

: the device and logs were received and were evaluated by a philips product support engineer.There is no evidence of chemical residue on the connector pins or inside the battery compartment.There is some corrosion at connector pins 4, 8, & 10 (eeprom pin, spo2 pins 4 & 6).There is no corrosion at the battery contacts in the battery compartment of the device.The bonds between the silicone membrane and the battery contacts are intact.The noted corrosion has not reached a point where it would impact connectivity between the mx40 connector and the patient cable or affect acquisition of ecg signals.The device was powered up using a pse lab rechargeable battery and also with the battery adapter tray that was returned with the device (with pse lab (b)(6) mn1500 batteries).The device was struck to simulate bump/drop events.With the philips rechargeable li-ion battery installed, hard strikes to the device did not result in power interruption.With the battery adapter tray returned with the device installed, moderate strikes resulted in momentary power interruption and reboots.The device was powered up, connected to an ecg simulator, and simulated conditions were created to test device functionality.Heart rate alarms were set (by customer) to low 45 ¿ high 130.Simulated heart rates of 30 and 240 (as available at the simulator being used) resulted in ***brady and *** vtach alarms.The device was also put through full functional testing at one of the mx40 production test stations.The device passed all functional testing.The device was opened to determine whether or not it had been opened/modified outside the philips factory.It was confirmed that the subassemblies are original to the device.Device was reassembled and checked to confirm functionality.The lot code of the battery adapter tray is 17/04.The manufacture date was 2017 ¿ week 4.The tray has been in use for around 2 ½ years.Note that the mx40 ifu instructs users to replace the battery adapter tray every 12 months or when visible wear is recognized.The battery adapter tray shows considerable wear and some damage.There is some wear to the silicone over-mold near the recess for the locator peg (of the mx40 battery compartment).This is consistent with placing the tray into the device with the recess seated above the locator peg and then pressing down to seat the tray.There is damage to the outer surface of the flex circuit related to reversed placement of the tray into the battery compartment.There is some tearing of the flex circuit.There is some corrosion at the middle position positive battery contact and at all of the negative position battery contacts.There is also some staining of the insulated areas of the negative end of the flex circuit where there was contact with the batteries.The flex circuit is beginning to separate from the plastic tray.The wear and damage noted is consistent with incorrect handling during insertion/removal of the tray and during cleaning and disinfection.See the attached pictures of the tray.The mx40 pwm log shows that the batteries were replaced in the mx40 on (b)(6) 2019 at 12:38:42.Battery voltage was 4706mv.The log shows that batteries were replaced again on (b)(6) 2019 at 06:48:16.Battery voltage was 4692mv.Note that the mx40 pwm log does not capture alarm information and does not log device shutdown time.The piic logs show that the device went offline at 04:02 on (b)(6) 2019.When the device powered down, communication with the piic ended (captured in the piic logs), and a ¿no data tele¿ inop would have been provided at the piic (displayed in the patient sector) to notify users that monitoring was no longer being performed.The piic audit logs do not show any low or replace battery inops leading up to the time the mx40 went offline.This indicates that the batteries were not in a low voltage state at the time, and that battery power was interrupted (either via a device impact that caused the batteries to come out of the tray/device, or via removal of the batteries from the device.The shutdown of the device was not related to battery depletion.The logs also show five alarms generated for * multiform pvc events in the hour prior to the device going offline.The logs show that the device came back online at 06:48 on (b)(6) 2019.This is the time at which the device was powered up again and established connection with the piic.An ***asystole alarm was generated at 06:48 on (b)(6) 2019.This indicates that when the device was powered back on and monitoring was resumed, the patient¿s condition was recognized and an alarm was provided to alert users to the patient¿s condition.Based on piic log information, the generator testing was initiated at about 05:00 on (b)(6) 2019.This is based on loss of communication between multiple mx40s and the piic.The incident/loss of monitoring for this device was not related to the generator tests, as the device powered down an hour prior to the start of the generator tests.There was no device malfunction.Evaluation and testing confirmed the device is operating as specified.The loss of monitoring was related to the device powering down (batteries removed).

Manufacturer Narrative

An analysis of the reported incident was conducted by a philips product support engineer (¿pse¿).A review of the mx40 patient worn monitor (pwm) llogs, piic clinical audit logs (¿logs¿), and an evaluation of the device were was performed.The mx40 pwm log demonstrates that the aa batteries were replaced in the mx40 on (b)(6) 2019 at 12:38:42p.M.At a voltage of 4706mv.The mx40 pwm log shows that batteries were replaced again on (b)(6) 2019 at 06:48:16 a.M.At a voltage of 4692mv.As the mx40 pwm log does not capture alarm information or device shutdown time, clinical audit logs from the piic were reviewed.Based on piic log information, the generator testing appears to have been initiated at approximately 05:00 a.M.On (b)(6) 2019; this indication is based on the piic logs information that shows based on the loss of communication between multiple mx40s and the piic between 05:06:20 a.M.And 05:07:21 a.M.Therefore, the incident concerning the/ loss of monitoring for this device was not related to the generator tests, as the device powered down an hour prior to the start of the generator tests.The logs further indicate that the mx40 came back online, reestablishing connection with the piic at 06:48:40 a.M.On (b)(6) 2019.An ***asystole alarm was generated at 06:48:46 a.M.On (b)(6) 2019.This indicates that when the device was powered back on and monitoring was resumed, the patient¿s condition was recognized and an alarm was provided to alert users to the patient¿s condition.The patient expired at 07:15 a.M.The device was tested and passed for functionality.Based on our investigation, the functional testing results and log review indicate that the interruption of patient monitoring was related to the device powering down when the batteries were removed.The device remains at the customer site.Reporter info updated to correct name.

• 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: 9311596
• MDR Text Key: 166116996
• Report Number: 1218950-2019-08574
• 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,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2017
• 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
• Patient Age: 59 YR
• Patient Weight: 83