MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS M3150 UPGRADE REL N.0; CENTRAL STATION MONITOR

Model Number 865423

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Death (1802)

Event Date 12/14/2016

Event Type  Death  

Manufacturer Narrative

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

Event Description

A patient monitored by an m4841a telemetry device at the information center expired on (b)(6) 2016.The patient was expected to have been monitored continuously with sp02 however staff said that after a change of the telemetry battery the device reverted to spot-check mode and not continuous monitoring mode for sp02.It was indicated that the device was a factor in the death of the patient.A patient death occurred.

Manufacturer Narrative

The customer called the customer care solutions center for troubleshooting support.The biomed at the site went into unit settings and found the default for sp02 was set to spot check mode.He changed the setting to continuous sp02 and tested the system after this change and found the device was operating as expected, however the issue occurred again prompting further investigation.A field service engineer (fse) went on site and attempted to replicate the issue since the customer said that after the batteries were changed the device went back to spot check mode again.He was unable to replicate the behavior.The m4841a device repeatedly adopted the settings each time he removed the batteries and replaced them.During a subsequent report of this issue in (b)(6), it was determined that the issue had occurred due to the fact that users were allowing the batteries to drain and totally deplete before replacing them, which alters the behavior of the telemetry device when it attempts to conserve power.The customer received information from the solutions center national support specialist who worked with a clinical resource to determine that the m4841a device behavior is such that during a low battery condition, in an effort to conserve power, the device will prioritize network connectivity and ecg monitoring while changing sp02 monitoring from continuous to spot check/off.Once the battery is depleted and the device shuts off, it will then revert to its last known state when powered back up again which was sp02 in spot check/off mode due to the prior low battery condition.The customer was provided with a copy of the instructions for use as a reference.The device remains in use.No malfunction of the device occurred.Staff were allowing batteries to completely drain to the point where the device would power off and prior to shutting off, when the power was low, the device would attempt to preserve power and preferentially disable continuous sp02 mode and revert to spot check/off mode.This was the setting the device would return too when a new battery was inserted.Use of the product has been determined to be a factor in the death of the patient though no malfunction occurred.

• Brand Name: M3150 UPGRADE REL N.0
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: richa shah ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6223620
• MDR Text Key: 63889647
• Report Number: 1218950-2016-08181
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2016

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: 865423
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 01/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2013
• 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; Other