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

Model Number 866389

Device Problem No Audible Alarm (1019)

Patient Problems Ventricular Fibrillation (2130); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2023

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.(b)(6).

Event Description

The customer reported that a patient was in ventricular tachycardia (vtach) for 10 minutes and the nurses weren't alerted, as the speaker in the central station didn't sound.The patient is near death and is in the intensive care unit (icu).The speaker was reconnected to the central station.

Manufacturer Narrative

A philips clinical consultant provided additional information.The patient was connected to remote telemetry (mx40), which was streamed to central monitor at the nurse's station.The customer alleged that the central monitor failed to alarm at time of ventricular fibrillation (vf).The patient went into vf arrest at 10:14, was found by wife at 10:28, and code blue was called by the nursing staff.No alarm for the vf arrest was heard.The patient has since died.The following functional tests were performed: per the customer, the speaker was reconnected to the central station to resolve the issue.A good faith effort (gfe) was performed to determine how the speaker became unplugged, and it was provided that it is unknown how it became unplugged.Once reconnected, the central station speaker functioned as intended.On the (b)(6), the patient went into a critical red alarm situation 10 times.The critical alarms were either xbrady, vt or asystole.The customer had the audible latching option switched on for all red alarms.The red alarm latching alarm stopped when acknowledged at the central station.On the (b)(6), the patient went into asystole 5 times.Because of the latching setting, these alarms continued to audibly alarm at the central for a considerable period of time.On one occasion on (b)(6) 2023, the red alarm was alarming for 34 minutes.Leading up to the patient incident on the (b)(6) 2023, the patient again triggers a large number of alarms, including 11 separate red alarms from midnight until 10:19am.These alarms continued to audibly alarm at the central until they were silenced.Some of these red alarms continued to alarm for over an hour before they were silenced.The patient had an asystole alarm at 09.32 which was acknowledged at 10.15, where the alarm was silenced at the central as it was only investigated 4 minutes later when the patient arrested again and was subsequently found by his wife.According to the clinical consultant, the main reason behind this incident is that the central monitor alarms were largely ignored.While this may have been partly because of the speaker, it would only have taken someone to review the patient¿s data that he was deteriorating.Furthermore, when the red alarms were actively acknowledged at the central, it seems the medical team did not review the alarm and the patient¿s condition.Based on the information available and the testing conducted, the cause of the reported problem was the connection of the speaker.The reported problem was confirmed.

• 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: 17301664
• MDR Text Key: 318890660
• Report Number: 1218950-2023-00484
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K153702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• 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?: No
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 07/05/2023
• Supplement Dates FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Life Threatening; Death
• Patient Sex: Male