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

Model Number 866389

Device Problem Device Alarm System (1012)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 05/11/2020

Event Type  Injury  

Manufacturer Narrative

Customer did not provide serial number.A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported ongoing alarm issues at their philips intellivue information center (piic) which led to an unspecified patient incident on (b)(6) 2020 in room 651 at 10:04 hours.

Manufacturer Narrative

H10: the biomed detailed the alarm issues within their telemetry unit.There was a delay of alarms going to their phones, and there are rooms where the alarms do not alarm to the phones (including room 651).A philips field service engineer (fse) was paged to assist the customer.Additional information was requested from the fse, but not received.No subsequent calls were noted.The device remains in use at the customer¿s 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: 10301702
• MDR Text Key: 199670411
• Report Number: 1218950-2020-04210
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

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: 06/24/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening