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 Cardiopulmonary Arrest (1765); Death (1802)

Event Date 11/20/2019

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.The risk manager reviewed and discussed the mx40 log with the remote application specialist (ras).The risk manager noticed a gap in the log between 0726 and 0802.The risk manager requested insight from the ras on the possible cause by asking, ¿if the battery was still low at 0726 and did not lose power until 0802, why do we not have any readings?¿ the ras reviewed the logs and explained, "the initial alert for no spo2 battery low generated first indication that spo2 will no longer be monitored due to low battery, followed by the tele batt empty alert one second after." additional information is being gathered for details on the event and device involved.

Event Description

The risk manager of the facility reported a patient that was being monitored by the mx40 telemetry device required resuscitation and expired on (b)(6) 2019.

Manufacturer Narrative

H10: a philips field service engineer (fse) went to the customer site and retrieved the mx40 pwm log and philips intellivue information center (piic) audit log, piic rfda log, and piic device debug log.Neither the mx40 telemetry device (mx40) nor its battery adapter tray were made available for evaluation; therefore, philips could not evaluate the performance of the battery.A philips product support engineer (pse) reviewed the manufacturing history of the mx40 and logs from the mx40 and the piic.The mx40 pwm log shows a fully charged battery being installed at 23:19 on nov 19, 2019, and then a fully charged battery is installed again at 08:01 on nov 20, 2019.This indicates a run time of only 8 hours and 40 minutes (with spo2 monitoring being performed).This short run time is consistent with the age and cycle count of the battery.This run time is also consistent with the data in the piic audit log.The piic rfda log shows the loss of association between the mx40 and the piic at 07:26 on nov 20, 2019.The rfda log shows the association of the mx40 to the piic (after battery replacement) at 08:02 and 08:04.Possibly reflecting power up, removal of battery, and reinsertion of battery.The piic device debug log was reviewed but does not contain data related to the device shutdown.Based on our investigation, the mx40 were working as designed.The pse's review was provided to the customer.The device remains at the customer's site.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the 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
• MDR Report Key: 9418115
• MDR Text Key: 169291967
• Report Number: 1218950-2019-09215
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Weight: 61