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

Model Number 865350

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Low Oxygen Saturation (2477)

Event Date 02/11/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

A patient death was reported.The patient was setup for continuous sp02 monitoring.The customer alleged that the mx40 device went into manual sp02 mode from continuous mode and that the spo2 monitoring and spo2 alarming ceased.The customer alleged that the patient later had a low oxygen level and expired.The customer stated that lack of spo2 monitoring may have contributed to the patient death.Investigation is required to determine if the mx40 device caused or contributed to the adverse patient event.

Manufacturer Narrative

The mx40 was sent to the factory and was tested by the product support engineer (pse).Per the pse, a philips li-ion rechargeable battery was inserted into the mx40 to power it on.Once the mx40 completed the boot up cycle, the spo2 setting was checked.It was confirmed that spo2 was set to continuous.The pse connected the patient cable and the spo2 sensor led powered on.The pse placed the sensor on his finger and a continuous spo2 measurement was initiated and spo2 measurements were acquired.The spo2 sensor was then disconnected from the patient cable.A ¿spo2t no sensor¿ inop was provided.He silenced the inop and the spo2 parameter was no longer displayed.He reconnected the spo2 sensor and the led powered on.He placed the spo2 sensor on his finger and spo2 a continuous measurement were initiated and spo2 measurement data displayed.The mx40 pwm performed normally and as expected for the selected spo2 setting (continuous mode).Per the piic ix audit logs that were provided by the fse, there was a low spo2 alarm generated at 1:29 where two reminders were also provided at approximately ~2-3 minute intervals.The low spo2 ended at 1:34.There was also a silence generated at 1:34 and spo2 was shut off at the same time.Per clinical specialist (b)(4), at 1:34 an inop sound was playing; it was silenced in the piic ix 232 sector and spo2t was automatically shut off.This is most consistent with the "sensor off" as per the instruction for use (ifu).Per the mx40 b.0 instruction for use (ifu) 4535 643 15721 page 9-9, there is a spo2 warning; "removal of the spo2 sensor from the mx40 patient cable during continuous spo2 monitoring results in a "no sensor" technical alarm.Silencing this alarm turns the spo2 measurement off, however the spo2 module is still operating in the background and consuming battery power.If you do not intend to resume continuous spo2 monitoring, change to manual mode.There is no technical alarm for a "no sensor" condition in manual mode." per (b)(4), there is no "sensor off" audited in the software revision the customer was using (b.02.03).Once spo2 monitoring is turned off there would be no spo2 numeric displayed at the piic sector and no pleth wave being displayed.Other parameters would be displayed instead.This change in the sector would be noted by the user during normal observance of the display sector after silencing of the "sensor off" inop message.There is a default spo2 configuration mode in the piic ix (manual, auto or continuous) and the device operates per that configuration until changed at either device (mx40 or piic ix).The spo2 configuration setting stays that way until patient discharge or the mode is changed.The configuration remains even through battery changes.No device malfunction occurred.The investigation has found that the issue is most consistent with spo2 monitoring being turned off due to a spo2 "sensor off" alarm being silenced at the piic ix.Testing of the mx40 device found the device performing to specification.The results of the investigation were provided to the customer via formal letter of response.No parts were replaced.

• 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: 7358373
• MDR Text Key: 103083506
• Report Number: 1218950-2018-02713
• 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
• Report Date: 02/23/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/21/2018
• Supplement Dates Manufacturer Received: 02/23/2018
• Supplement Dates FDA Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2015
• 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