MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC 3 LEADS SET DISPOSABLE, BEDSIDE IEC RD

Model Number 989803174201

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 05/17/2022

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 electrode l of the ecg cable began to burn the patient.The device was in use at time of event, a minor burn was reported.

Manufacturer Narrative

The device was returned to philips.Visual inspection of the lead set found that the lead set has burn damaged on wire for the yellow grabber.It cannot be confirmed if the cable is fatigued, or damage was caused by tension on the lead set.The lead set could not be functionally due to hazard of exposed wire.The customer has ordered the replacement part to resolve the issue.The device will be held in the mcs lab for further review if required.

Event Description

It was reported to philips that the electrode l of the ecg cable began to burn the patient.The device was in use at time of event, a minor burn was reported.

• Brand Name: 3 LEADS SET DISPOSABLE, BEDSIDE IEC RD
• Type of Device: 3 LEADS SET DISPOSABLE, BEDSIDE IEC RD
• 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: 14620967
• MDR Text Key: 293499750
• Report Number: 1218950-2022-00461
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K110287
• 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: 989803174201
• Device Catalogue Number: 989803174201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 08/22/2022
• Supplement Dates FDA Received: 09/08/2022
• 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): Required Intervention