MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PATIENT INFORMATION CENTER IX

Model Number 866389

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/02/2021

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that staff were silencing red alarms without checking on the patient which led to a patient death.

Event Description

It was reported that staff were silencing red alarms without checking on the patient which led to a patient death.

Manufacturer Narrative

A philips remote clinical application specialist (cas) spoke with the customer.The customer indicated that a patient passed away as a result of their alarm being silenced by staff and the patient not being checked on.No allegation of malfunction was alleged against the patient information center (pic) device.A philips field service engineer (fse) was dispatched for onsite service.Logs were collected by the fse, however the nurse unit manager could not recall the day that it happened.An investigation into the logs could not be performed as the date, time and bed label information were not provided by the customer.Good faith efforts were made by the key market to obtain additional information associated with this complaint evaluation, but attempts have been unsuccessful.If additional information is later obtained, the complaint will be reopened.There was no product malfunction.This is considered a user issue.No further investigation or action is warranted at this time.Data logs were collected but could not be reviewed as the customer provided insufficient information regarding the event.

• Brand Name: PATIENT INFORMATION CENTER IX
• Type of Device: PATIENT INFORMATION CENTER IX
• 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12447070
• MDR Text Key: 270543706
• Report Number: 1218950-2021-10908
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: 00884838048645
• 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,User Facility
• 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?: No
• 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
• Distributor Facility Aware Date: 09/02/2021
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 11/08/2021
• 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): Death