MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP20 INTELLIVUE PATIENT MONITOR; COMPACT PATIENT MONITOR

Model Number M8001A

Device Problems Loss of Power (1475); Battery Problem (2885)

Patient Problem Death (1802)

Event Date 02/17/2016

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported that the monitor failed and shut off; the clinician didn't realize the state of the batteries.The customer wanted information to see if the equipment is working correctly.Philips became aware of the issue when the affected device arrived to the repair bench and a philips field service engineer called the customer to get more information.It was then when the customer reported the death of the patient.The patient death occurred, while transporting the patient.

Manufacturer Narrative

A customer field service engineer (fse) tested the equipment, and the device has been working with new batteries provided by the customer, and the batteries have been working for ten hours more or less in demo mode.When the batteries do get low, the monitor does provide an inop alarm of "low battery".The fse heard the beep sound when the device is in low battery; there were no sounds when battery is charging or with more than 20 minutes of battery remaining.The fse doesn't believe the batteries that were being used during the event are available for testing.The fse does not believe there is a problem with the device.The device was tested by the fse, and returned to service.No subsequent calls have been logged for this device/issue.No malfunction of the device was able to be found.No further investigation is warranted at this time.

• Brand Name: MP20 INTELLIVUE PATIENT MONITOR
• Type of Device: COMPACT PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: richa shah ; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 5674027
• MDR Text Key: 45745399
• Report Number: 9610816-2016-00146
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K030038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

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: M8001A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2009
• 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