MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX

Model Number 866389

Device Problem Defective Alarm (1014)

Patient Problem Cardiac Arrest (1762)

Event Date 11/24/2023

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.A philips technical consultant (tc) went to the customer¿s site and checked the mx40 logs, event logs, and pic ix configuration.The tc verified alarms on mx40 properly worked and sent the customer feedback.Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

The customer reported the unit did not alarm on (b)(6) 2023 at 0905, a code blue was called after the patient was found unresponsive by the licensed practical nurse (lpn).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 passed away.The mx40 telemetry device in use during this event is reported in mfr number 1218950-2023-00955.

Manufacturer Narrative

A philips remote service engineer (rse) remotely interviewed the customer who was onsite.The rse decided to dispatch a philips technical consultant (tc) onsite to further investigate and to collect the logs to be reviewed by an internal philips product support engineer (pse).The tc verified alarms activated whenever simulated thresholds exceeded.He found there were no issues.The internal philips product support engineer (pse) examined the same logs reviewed by the tc and found that 7 north bed label 725b was the one most frequently indicated in the alarm logs during the time period in question, first indicating the asystole at 8:23:08 on (b)(6), roughly 40 minutes prior to the customer assertion.Bed 725b shows multiple asystole alarms over the time period of concern, each looks to have been silenced at the central.The device remains at the customer site.No further investigation or action is warranted at this time.

Event Description

This report is based on information provided by our philips complaint handling team.An 85 year old male was admitted on (b)(6) 2023 for low hemoglobin in the setting of dyspnea on exertion (doe) due to diastolic congestive heart failure (chf) and aortic insufficiency.The patient was being followed by the heart failure team and was transitioned from intravenous piggyback therapy (ivpb).The patient received 1 unit of packed red blood cells (prbc) on this admission and their complete blood count (cbc) was being monitored.There was an order for telemetry monitoring beginning (b)(6) at 08:50.The palliative team was consulted on this admission, and patient wished to remain full code.Philips received a complaint on the patient information center ix sn (b)(6) indicating that nursing leadership reviewed the telemetry monitor disclosure and it was identified that the patient went into asystole at 08:24 with pacer spikes firing.The customer alleged the central monitor did not alarm asystole until (b)(6) 2023 at 09:04.At 0905, a code blue was called after the patient was found unresponsive by the licensed practicing nurse (lpn).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.Advanced cardiac life support was initiated.Return of spontaneous circulation was unable to be achieved and the patient expired.The official cause of death was cardiac arrest.It was not unconfirmed whether the pacer detection was on or off at the time of the event.

• Brand Name: PATIENT INFORMATION CENTER IX
• Type of Device: PATIENT INFORMATION CENTER IX
• 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: 18400290
• MDR Text Key: 331415205
• Report Number: 1218950-2023-00967
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211900
• 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: 866389
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2011
• 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