MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH RADIO TRANSLUCENT ECG LEADS; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number (240) 11297402

Device Problems Defective Device (2588); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2021

Event Type  malfunction  

Event Description

Receiving a bad tracing from ecg.Patient wasn't connected yet.Lead wires changed 2 times which finally resolved issue.The oem lead sets from siemens appear to have manufacturing product defects.Some leads look physically different and may not be making a good connection.Fda safety report id# (b)(4).

• Brand Name: RADIO TRANSLUCENT ECG LEADS
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH
• MDR Report Key: 12615612
• MDR Text Key: 276350269
• Report Number: MW5104517
• Device Sequence Number: 1
• Product Code: LNH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: (240) 11297402
• Device Lot Number: (10) 060321
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other