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

Model Number 866389

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 01/03/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported a patient code event and subsequent death in icub on (b)(6) 2019 and requested assistance with data collection as there was a potential for litigation indicated.The customer did not allege a product malfunction but requested data collection and audit logs for their records.It has not been confirmed if a delay in response to the patient may have occurred.The patient died.

Manufacturer Narrative

No formal evaluation of the device was requested and none was performed.A philips field service engineer (fse) was paged to respond and contact the customer and worked with a local clinical resource to help the customer gather documentation for their records.The customer has specifically indicated that they are not requesting philips to collect any data for the evaluation of this issue and declined to provide further details.The customer has instructed that their is no indication of any device malfunction or alleged contribution of the device to the patient event.The customer stated they only wanted assistance collecting information for their records.The customer said they were assisted in getting the data they required and had no further requests from philips.No device malfunction was alleged and there is no data to support any malfunction occurred.The device is not deemed a factor in the incident per information provided by the biomedical engineer.No further action or investigation is warranted.

• Brand Name: INTELLIVUE INFORMATION CENTER IX
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8236878
• MDR Text Key: 132757782
• Report Number: 1218950-2019-00313
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: (01)00884838048645
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2019
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2018
• 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