MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH PHILIPS NMT ACCELEROMETER TWITCH MONITOR; STIMULATOR, NERVE, PERIPHERAL, ELECTRIC

Model Number 989803174581

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 05/28/2021

Event Type  malfunction  

Event Description

Pt burned by nmt cable.Fda safety report id# (b)(4).

• Brand Name: PHILIPS NMT ACCELEROMETER TWITCH MONITOR
• Type of Device: STIMULATOR, NERVE, PERIPHERAL, ELECTRIC
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
• MDR Report Key: 11965559
• MDR Text Key: 255372731
• Report Number: MW5101762
• Device Sequence Number: 1
• Product Code: KOI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other