MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX450 PATIENT MONITOR

Model Number 866062

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 04/15/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that they received electric shocks from the mx450 device.The device was not in use at the time of event, but the user had an electric shock.

Event Description

It was reported on (b)(6) 2022 that the patient received electric shocks from the mx450 device.When the device put the plug in the mains, it caused a spark.This had happened to several users.The device rack also receives electric shocks when connected to the mains.The device was in normal use (except the power cord is probably replaced with ragged power cord not delivered with the medical equipment per biomed).The remote service engineer (rse) was consulted on the case and was able to confirm that the device was pulled from usage and no injury or treatment was had from the issue.The rse spoke with the biomed onsite and was able to determine that the wrong cable for the device was being used when the issue occurred.The mx450 was sent to bench repair and received on may 11th, 2022 to confirm the issue of the cable being the cause of the shock.After arriving to bench, the used cable was confirmed to be an alternative power cable (not the one provided by philips) with a broken earth conductor, thus it didn¿t pass electrical safety tests when being plugged into a wall connector and exhibited sparks as stated.The device was working as expected after the bench repair with no internal connections or groundings being damaged.The not original non philips power cord was damaged and replaced with the original power cord.The issues were found with the mx450 and was deemed fully functional.

• Brand Name: INTELLIVUE MX450 PATIENT MONITOR
• Type of Device: INTELLIVUE MX450 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14341619
• MDR Text Key: 291276363
• Report Number: 9610816-2022-00234
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038769
• UDI-Public: 00884838038769
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K130849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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
• Device Catalogue Number: 866062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2022
• Initial Date FDA Received: 05/09/2022
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2018
• 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): Required Intervention