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

Model Number 865350

Device Problem Device Alarm System (1012)

Patient Problem Death (1802)

Event Date 03/29/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

A patient death occurring on (b)(6) 2020 was reported to philips by the hospital.The hospital's nurse manager stated that according to staff, for 3 hours there were no alarms.He also stated that there is a unit secretary who sits at the desk next to the piic ix pc and that they claim they did not hear or see any alarms.The customer requested clinical audit logs from unit cvru be pulled for review.The incident timeframe was reported to be between 11:43-15:53.

Manufacturer Narrative

A philips field service engineer (fse) went on site to retrieve the mx40 pwm log and philips intellivue information center (piic) audit log, piic rfda log, and piic device debug log.The mx40 telemetry device (mx40) was not made available for evaluation, only pictures of the mx40 was obtained.A philips product support engineer (pse) reviewed the logs from the mx40 and the piic, and pictures of the mx40.The pse¿s review of the piic audit log confirms that beginning at 11:43 a series of ecg leads off alarms were displayed by the piic and were resolved at the patient location or silenced at the piic by the staff.There was a !!ecg leads off condition beginning at 12:51 that persisted until 15:51, at which time it was resolved.The alarm was silenced at 13:04.Reminder alarms were provided at 3-minute intervals until 15:51, with a reminder alarm being silenced at 14:05.Concerning the multiple ecg leads off and !!ecg leads off alarms during the time that this patient was being monitored, page 59 of the intellivue mx40 instructions for use (ifu) states that problems with ecg signal can stem from, ¿patient-related sources¿ such as poor skin prep, dry electrodes, and poor electrode adhesion, as well as by patient motion and muscle artifact.¿ additionally, page 48 of the ifu advises that re-attaching the leads to the patient would resolve the alarms.The mx40 pwm, piic audit, piic rfda, and piic device debug logs do not show any loss of communication between the mx40 and the piic during the time the patient was being monitored, other than when battery changes were performed; no reboot events occurred during this time.The pse reviewed the pictures of the mx40 provided by the hospital.The pse did not observe any visible issues with the mx40 or corrosion at either the connector pins or the battery contacts in the battery tray.Based on our investigation, the mx40 was working as designed.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.H3 other text : the device was not made available for field service evaluation.

• 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: 10025111
• MDR Text Key: 189871231
• Report Number: 1218950-2020-02647
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: (01)00884838082236
• 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: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR