MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX450 PATIENT MONITOR

Model Number 866062 (MX450)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Heart Failure (2206)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported a heart failure.Unknown, no further information is available at the time of the initial report.

Manufacturer Narrative

During the investigation, it was determined that the reported issue was not related to a heart failure and there was no serious injury or patient harm.The customer reported that no heart rate values were displayed and the intellivue mx450 patient monitor showed a "ecg leads off" inop on the display.The field support engineer (fse) went for onsite service and confirmed the reported issue.During the investigation of the intellivue mx450 patient monitor the fse found that the ecg cable was defective and that the part needed to be replaced.The philips fse confirmed that the intellivue mp70 worked as specified.The device worked as intended and no product malfunction could be identified.The reported issue was caused by a faulty ecg lead set.The customer was informed accordingly by a field service engineer.The product remains at the customer site.No further investigation or action is warranted.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.

Event Description

The customer reported a heart failure.

• Brand Name: INTELLIVUE MX450 PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 9322782
• MDR Text Key: 166421185
• Report Number: 9610816-2019-00303
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K130849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 866062 (MX450)
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1