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

Model Number 865350

Device Problem No Device Output (1435)

Patient Problem Death (1802)

Event Date 12/08/2018

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.Patient information has been requested not available at time of report.

Event Description

The customer reported that they took the mx40 off an expired patient yet it showed an ecg waveform.

Manufacturer Narrative

The device was not returned for evaluation.The customer requested information on ecg monitoring behavior: whether providing waveforms on an expired patient is normal, a pea for example.Pulseless electrical activity (pea), also known as electromechanical dissociation, refers to cardiac arrest in which the electrocardiogram shows a heart rhythm that should produce a pulse, but does not.The customer was advised it could possibly have been a pea rhythm.Strips from the device was reviewed and was said to show a normal rhythm with periods of inop (leads off), then a period during which the device is trying to learn (the rhythm).During the learn period, the waveform is still reasonably good.No additional information was provided.The cause of the event remains unknown.The device remains at the customer site.If the device is returned for evaluation or additional information is received, the complaint will be reopened for investigation.

• 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: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8248961
• MDR Text Key: 133187982
• Report Number: 1218950-2019-00475
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: (01)00884838082236
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

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: 865350
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 12/17/2018
• Supplement Dates FDA Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2014
• 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