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 Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 12/07/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported that on (b)(6) 2020, a patient went into cardiac arrest and expired.The patient was assigned to tele #11 in rm 202 in the med/surg unit.The customer reported having trouble with maintaining the ecg rhythm on a philips information center ix (pic ix) / m4841 telemetry system.

Manufacturer Narrative

H10:a philips remote service engineer (rse) received a call back form the customer nurse manager.The nurse manager explained that the m4841 telemetry device was not actually used with the patient, and they did not admit the patient into the philips pic ix system.The patient was actually hardwired to a non-philips device, and they will not need an investigation from philips at this time.Further information was request for the type of device, but no further details were received.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.H3 other text : customer called stating a philips device was not in use for this reported 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: 11004253
• MDR Text Key: 221447324
• Report Number: 1218950-2020-07758
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: (01)00884838048645
• 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: 12/10/2020

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: 12/10/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR