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

Model Number 865350

Device Problem Alarm Not Visible (1022)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/01/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reports that they entered the patient's room and noted that patient's oxygen saturation was 46, and that alarm was off on the bedside monitor.The patient was immediately placed on 100% nrb (non-rebreather mask), hospital staff was notified.Oxygen saturation rebounded to 100% but patient remained minimally responsive, eventually becoming more alert.The venous blood gas (vbg) showed hypercarbia.The patient was placed on bipap machine and transferred to intensive care unit (icu).The device was in use on a patient at the time of event.There was an adverse event reported.The nurse confirmed that the patient's o2 sat was 46, and failed to alert of the drop in oxygen saturation.

Event Description

The customer reports that they entered the patient's room and noted that patient's oxygen saturation was 46, and that alarm was off on the bedside monitor.The patient was immediately placed on 100% nrb (non-rebreather mask), hospital staff was notified.Oxygen saturation rebounded to 100% but patient remained minimally responsive, eventually becoming more alert.The venous blood gas (vbg) showed hypercarbia.The patient was placed on bipap machine and transferred to intensive care unit (icu).The device was in use on a patient at the time of event.There was an adverse event reported.The nurse confirmed that the patient's o2 sat was 46, and failed to alert of the drop in oxygen saturation.The service engineer was dispatched to the customer site to assess the clinical logs.The service engineer reviewed the logs and confirmed that the mx40 overrode the bedside settings, therefore, turning off the spo2 alarm when the patient was being moved to another central station.The product support engineer confirmed that it is normal behavior of the telemetry device to override the bedside device if the telemetry device is being used as the source of the ecg measurement.Based on the information provided by the field service engineer (fse) the issue resolved after changing the configuration at the piic ix central station, to always have spo2 alarms set to on by default.It was it is concluded that the reported problem was the result of an incorrect configuration.

• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14193251
• MDR Text Key: 289969499
• Report Number: 1218950-2022-00360
• 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: 04/01/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/22/2020
• 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): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female