MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING

Model Number 865350

Device Problem Disconnection (1171)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 10/14/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

An alarm review determined that a lead set was unplugged on an mx40 and subsequently the mx40 monitor went into standby.During that time, the patient coded and then expired.

Manufacturer Narrative

Good faith effort was made to obtain the device for evaluation but the device was not received at the repair bench for evaluation.Therefore, the issue could not be confirmed and the cause of this specific case could not be identified at this time.The customer reported that at the surveillance (central monitor) a ¿leads off¿ and lead set unplugged¿ alarms were stored but not noticed for a long period of time.Then it went into ¿standby¿.Patient coded sometime later.It is unknown if the device is the cause of the event.In the event that the device is returned, the record shall be reopened for further evaluation.

Manufacturer Narrative

From a technical standpoint, the loss of information due to the leads off and/or unplugged lead set would not put the mx40 in stand by automatically.This would have to be done by the unit shutting off using radio frequency (rf) auto shutoff but not executing standby mode command.Therefore, the mx40 would not come back on.Taking into account "leads off¿ and "lead set unplugged," if the lead set is unplugged or off there will be no data being sent to the mx40.Thus, its rf auto configuration will shut down the device after ten (10) minutes of no data being sent down the leadset or unplugged at the device.No connection would sustain its state in shutdown mode.In a leads off or leadset unplugged, regardless of what ever is occurring with the patient, there is no data being transmitted down the leadset to any device because they are considered to be off due to the state of being off or unplugged/disconnected.Hence, the piic will not alarm nor will the mx40, even if the patient coded.It would be impossible for the system to acknowledge due to this state.Regardless of when the leads off or unplugged occurred, there would be an inop alarm.It is stated the alarms were stored but not noticed for a long period of time.The unfiltered logs will state this.This will be considered user error as the alarms were not noticed for a long period of time and the system performed as designed.Further, if there were a leads off inop alarm, that would have been indicated at not only the mx 40 but the patient monitoring system (piic) at the nurses station.This would cause a blue inop alarm and an audible alarm would sound.Note: our alarms at the piic cannot be turned off.They can be set as low as ¿4¿.Still, this is loud enough for an individual to hear at the piic location and surveil.Our speakers at the piic are mounted and fastened with two thumbscrews.Our installers are cautioned to always make sure the speaker connections are tight enough so that if any individual were to remove the speaker, it would be considered intentional.Based on the evaluation, this will be considered user error as the alarms were not noticed for a long period of time and the system performed as designed.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 9216586
• MDR Text Key: 163109730
• Report Number: 1218950-2019-08000
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838048645
• UDI-Public: (01)00884838048645
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 49 YR
• Patient Weight: 90