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

Model Number 989803174581

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

Patient Problem Localized Skin Lesion (4542)

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

The device was returned to philips.Visual inspection of the cable found that there was damage to the external jacket of the cable.This is a mechanical defect from misuse at customer site.It is believed that the damage is the result of the sensor cable being pinched locally (just the insulation, not the full cable).Since the opening is quite small, it is difficult to detect when checking the cable before use.At the same time, since the opening is quite small, there should not be a real problem with that cable because it does not allow direct contact between internal shield and patient skin." the functional testing of this cable was performed using the philips intellivue mx550 patient monitor along with the philips nmt patient module.The cable was connected however the inop message "nmt leads off" was produced.There was no observed heating along the patient cable.The cable was scrapped in the lab and no further action will be taken with this sample.The customer reported the patient burn was treated with dressing and neosporin.No further actions were taken and none are warranted.

Event Description

The customer reported that the patient had a burn on thumb (blister).

• 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12545637
• MDR Text Key: 273735012
• Report Number: 1218950-2021-10965
• 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: user facility
• 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?: No
• Device Operator: No Information
• Device Model Number: 989803174581
• Device Catalogue Number: 989803174581
• Device Lot Number: 2017-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2021
• 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): Other