MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC EFFICIA CM120

Model Number 863302

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 11/19/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to philips that the patient was burned by the ecg electrode.The device was in use at time of event.Adverse event was reported.

Manufacturer Narrative

The customer reported a problem with the ecg electrode.The customer stated that they went with a 3rd party device to resolve the issue.A good faith effort was made to obtain additional information regarding customer resolution associated with this complaint, but there is no additional information available.H3 other text : went with 3rd party service.

Event Description

It was reported to philips that the patient was burned by the ecg electrode.The device was in use at time of event.Adverse event was reported.

• Brand Name: EFFICIA CM120
• Type of Device: EFFICIA CM120
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13017269
• MDR Text Key: 282322370
• Report Number: 1218950-2021-11186
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• 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 Model Number: 863302
• Device Catalogue Number: 863302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization