MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE INFORMATION CENTER IX; CENTRAL STATION MONITOR

Model Number 866389

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Cardiopulmonary Arrest (1765)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that on (b)(6) 2020 around 1:00 pm a patient needed to be resuscitated because their mx40 device had stopped working and was no longer sending data to the patient information center ix (pic ix).

Manufacturer Narrative

H10: a philips remote service engineer (rse) talked to the customer in order to troubleshoot the issue.The rse confirmed the reported issue and found that it had occurred due to the mx40's battery levels.The mx40 had lost power which resulted in no data being sent to the pic ix.The rse confirmed that no malfunction of the pic ix occurred and provided the audit logs showing a battery issue with the mx40 in question.The issue was resolved once the battery of the mx40 was replaced.The device remains on site and in use.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: INTELLIVUE INFORMATION CENTER IX
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11056906
• MDR Text Key: 223608230
• Report Number: 1218950-2020-08020
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening