MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC MX40 1.4 GHZ SMART HOPPING

Model Number 865350

Device Problem Defective Alarm (1014)

Patient Problem Tachycardia (2095)

Event Date 01/20/2022

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that the patient monitor failed to alarm for low spo2 / oxygen desaturation for approximately ten minutes.It was further reported that the patient subsequently experienced ventricular tachycardia (v-tach) and expired.

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that the patient monitor failed to alarm for low spo2 / oxygen desaturation for approximately ten minutes.It was further reported that the patient subsequently experienced ventricular tachycardia (v-tach) and expired.

Manufacturer Narrative

Section b event date was corrected.Philips healthcare investigated the issue.The audit logs were pulled and provided to philips by the field service engineer (fse) and were reviewed by the philips telemetry product support engineer (pse).Based on the log review, there were no spo2 desat alarms provided in the incident timeframe.There were several spo2t no pulse and spo2t noisysignal inop alarms throughout the incident timeframe.Spo2t no pulse inop indicates the pulse is too weak or not detectable.The spo2t noisysignal inop indicates there is excessive patient movement or electrical interference causing irregular pulse patterns.The noted spo2 inops are intended to alert users to issues that prevent the spo2 measurement from being calculated.There were ecg limit violation alarms (**yellow), vtach (***red), and asystole (***red) provided as the patient¿s condition changed/deteriorated.The rfda log does not reveal any losses of communication between the mx40 and network/pic ix during the incident timeframe.Based on the foregoing investigation, philips healthcare has determined that the issue reported to us is not consistent with a product malfunction.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13578399
• MDR Text Key: 285942597
• Report Number: 1218950-2022-00147
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: 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 Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 07/06/2022
• Supplement Dates FDA Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2017
• 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