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

Model Number 866389

Device Problem Alarm Not Visible (1022)

Patient Problem Death (1802)

Event Date 01/24/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported an asystole alert was not seen in the bed to bed overview.This occurred on (b)(6) 2021 shortly after 8:00 am.The alert occurred on bed its 11 on unit its 2.The patient died.

Manufacturer Narrative

H10: there was no product malfunction; this is considered a user issue.The reported asystole alarm had occurred, after a higher priority red alarm ("xbrady").As the higher priority xbrady alarm was already showing in the bed to bed popup window, as it had not been acknowledged, the asystole alarm was not seen as a bed to bed overview popup.This information was provided to the customer by the response center engineer.The device remains at the customer site.No further investigation or action is warranted at this time.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: 11271967
• MDR Text Key: 230025238
• Report Number: 1218950-2021-00737
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838052130
• UDI-Public: (01)00884838052130
• 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: 01/27/2021

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: 01/26/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Weight: 85