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

Model Number 866389

Device Problem No Audible Alarm (1019)

Patient Problems Ventricular Fibrillation (2130); Injury (2348)

Event Date 07/25/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported a patient in bed 18 was awaiting heart transplant had episodes of ventricular atrium blockage and ventricular fibrillation.At about 10.30 pm on (b)(6) 2020, the patient presented at least twenty ventricular fibrillation complexes not alarmed with a red alarm from the monitoring station.Emergency intervention was provided to the patient, thus this is considered a serious injury.

Manufacturer Narrative

A philips field service engineer (fse) went to the customer site.The fse could not confirm the issue while at the site.The fse was able to confirm that the patient was promptly rescued by the nurses, despite saying that the ventricular fibrillation alarms were not activated in the central unit.The fse collected available files for review.The files were sent to a philips clinical specialist (cs) for review.The philips clinical specialist (cs) believed the ecg signal was not good which resulted in the "failed to analyze ecg" technical alarms.The device remains at the customer site.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: 10378087
• MDR Text Key: 201997152
• Report Number: 1218950-2020-04581
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: (01)00884838093041
• 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: 08/05/2020

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: 07/31/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 07/31/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening