MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC INTELLIVUE NMT PATIENT CABLE

Model Number 989803174581

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Localized Skin Lesion (4542)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

A good faith effort was made to get the device back for evaluation , but there is no additional information available.The reported device is not available for evaluation therefore device evaluation data is not available.The customer reported the patient burn was treated with surgical debridement.No further actions were taken and none are warranted.

Event Description

The customer reported that the patient had a burn at site of electrodes and thumb.

• Brand Name: INTELLIVUE NMT PATIENT CABLE
• Type of Device: INTELLIVUE NMT PATIENT CABLE
• 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: 12559095
• MDR Text Key: 274212106
• Report Number: 1218950-2021-10973
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial

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: 989803174581
• Device Catalogue Number: 989803174581
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization