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

Model Number 865350

Device Problem Alarm Not Visible (1022)

Patient Problem Death (1802)

Event Date 09/20/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

The hospital's clinical manager (cm) reported to the hospital's biomed that a patient death occurred on (b)(6) 2020 at around 7:54 am, when the patient with an internal pacemaker was being monitored utilizing the pulse oximeter function of the mx40.The cm stated they believed there should have been a patient physiological alarm when the pleth on the pulse oximeter displayed the technical inop alarm, "no pulse" which occurred at 0754; however, there was no patient physiological alarm noted for it.

Manufacturer Narrative

A philips field service engineer (fse) reviewed the customer's experience and advised the hospital's biomed that "there is no alarm function for pulse rate." physiological alarms for pulse rate is not available with the current software revision that this mx40 has.The fse obtained the audit log from the hospital.Our philips product support engineer (pse) reviewed the audit log and the reported incident details.The pse found the fse¿s assessment to be accurate.He confirmed that this device is operating on software revision b.06.59.Physiological alarms for the pulse parameter is not available for mx40¿s with software revisions b.06.59 and lower.The pse advised there are technical inops available as noted by the cm who indicated they received, ¿spo2t no pulse,¿ inop.This message is to alert users of an issue with the measurement.The pse confirmed an inop sound for a ¿spo2t no pulse¿ inop event is played at the piic and the inop label will be displayed in the patient sector.The inop label for ¿spo2t no pulse¿ would not be captured in the audit log.Based on our investigation, the mx40 was performing as designed.The device remains at the hospital 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: 10591220
• MDR Text Key: 208704676
• Report Number: 1218950-2020-05685
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2020
• 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
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death