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

Model Number 865350

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Death (1802)

Event Date 04/10/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer's director biomedical and clinical engineering (htm) reports that on (b)(6) 2020 the patient was found expired by nurse at 11:30am mdt and reports no alarming for spo2.The customer reports that the device was showing a spo2 of 90 but the actual reading was supposed to be 71.The patient room was confirmed and the clinical audit trial shows alarming between 10-54am -12:28pm with equipment removal of the device at 13:18 mst.Investigation is being conducted to determine if the device caused or contributed to the event.

Manufacturer Narrative

H3 and h6: our philips field service engineer (fse) went to the site to obtain additional information.Neither the mx40 telemetry device (mx40) nor its battery adapter tray and pwm logs were made available for evaluation; therefore, philips could not evaluate the performance of the mx40 or its battery.Testing of the mx40 performed by your hospital¿s biomedical engineer found the device was performing as intended.While the mx40 device nor any additional event specific information was made available by the site¿s clinical staff, the fse was able to retrieve the philips intellivue information center (piic) audit log and a screen capture of the spo2 settings that were configured for the device.A philips product support engineer (pse) reviewed the device manufacturing history confirming that there were no anomalies noted during the manufacturing process.Further the pse reviewed the audit logs provided from the piic confirming that spo2 low limit violation alarms at 80%, 79%, and 78% were captured.The screen capture provided by the fse shows the desat limit setting of 80%.Based on the audit log information, the desat limit setting was below 78% (possibly 75% or 70%).However, without the additional information that was requested by the fse, philips is unable to determine how the device functioned during the incident.Based on our investigation and the information provided by the reporting facility, 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.

• 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: 9958599
• MDR Text Key: 187592029
• Report Number: 1218950-2020-02286
• 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: 04/13/2020

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 04/13/2020
• Supplement Dates FDA Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death