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

Model Number 865350

Device Problem Defective Alarm (1014)

Patient Problems Asystole (4442); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2023

Event Type  Death  

Event Description

It was reported: patient death - site is claiming the mx40 did not alarm.The device was in use on a patient.There was a report of patient death.

Manufacturer Narrative

A follow up report will be submitted after philips obtains more information concerning this event.

Manufacturer Narrative

The following functional tests were performed: logs were pulled and the mx40 and event logs picix configuration were checked by the philips field engineer (fse).The logs verified the alarm on the mx40 properly worked and no malfunction were noted.On (b)(6) 2023 at 0905, a code blue was called after the patient was found unresponsive by the licensed practical nurse (lpn).An advanced cardiac life support was initiated, return of spontaneous circulation was unable to be achieved and the patient expired.When reviewing the 20-minute telemetry disclosure, it was found that the patient had been asystole for 20 minutes prior to the code being called.The patient¿s pacemaker was spiking but there was no underlying rhythm.The central monitoring station did not alarm asystole until (b)(6) 2023 09:04.The patient was a 85 year old male admitted on (b)(6) 2023 for low hemoglobin in the setting of doe 2/2 to diastolic chf and aortic insufficiency.The patient was being followed by the hf team and was transitioned from ivpb bumex to bumex po.The patient received 1 unit of prbc on this admission and their cbc was being monitored.There was an order for telemetry monitoring beginning (b)(6) 2023 at 08:50.The clinical audit log and some excerpted logs information was provided and were reviewed by the product support engineer (pse) which shows that alarms were generated for changes in the patient¿s condition.The alarms were being silenced by staff.The data review confirmed that the device recognized the deterioration of the patient¿s condition and that alarms were provided for limit violation events.The trend and wave review data shows that the device recognized changes in the patient¿s condition.The alarm review data provided does not cover the entirety of the incident timeframe but does show a variety of alarms during the periods the strips were provided for.The excerpted audit log information, attached to the complaint contains additional alarm information (with silence activities) from the incident timeframe.The available information indicates the device was functioning as specified and that alarms were being provided as appropriate for changes in the patient¿s condition.Based on the information available, the cause of the reported problem was confirmed to be user error.The alarms functioned as configured as intended based off the original configuration sign-off.An update to the assessment was performed for clarification.It was reported the monitor did not alarm for asystole and the patient passed away.This 85-year-old patient was admitted for low hemoglobin, exhibiting dyspnea on exertion secondary to congestive heart failure and aortic valve insufficiency.After receiving one unit of blood the patient was placed on telemetry (mx40) for monitoring.At one point, the nurse found the patient unresponsive and in asystole, for which a code blue was called with the patient subsequently passed away.It was indicated the patient was in asystole for 20 minutes prior to being found and the patient's pacemaker was delivering impulses but there was no capture; therefore, the patient had no underlying rhythm.The central station (pic) did not generate an alarm for asystole until just prior to the code blue.At this time, it appears the device may have caused or contributed to the reported event re-assessment was performed by the pms clinical expert based on new information received in the complaint record.Incomplete clinical audit logs were returned for investigation and a review was performed by a product support engineer, revealing several alarms were generated for changes in patient condition during the incident timeframe.These alarms and alarm reminders were silenced by users during the same timeframe.Based on this information, the device did not cause or contribute to the reported event.It appears alarm management may have been a factor; however, the cause remains unknown.Based on the information provided in the case, the alarms functioned as configured and as intended and confirmed to be operating per specifications as indicated in the logs and confirmed by the fse and pse.The alarms were silenced by users during the same timeframe.The customer was provided with a feedback.

Event Description

Philips received a complaint on the mx40 1.4 ghz smart hopping indicating the monitor did not alarm for asystole and the patient expired.The device was in use on a patient.There was a report of patient death.

• 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 rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18354767
• MDR Text Key: 330874169
• Report Number: 1218950-2023-00955
• 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

• Date FDA Received: 12/19/2023
• 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
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2014
• 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
• Patient Age: 85 YR
• Patient Sex: Male