MAUDE Adverse Event Report: TZ MEDICAL LIFELINKS; DEFIBRILLATION / CARDIOVERSION PADS

Model Number P-211-M1

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burn(s) (1757)

Event Date 09/10/2014

Event Type  malfunction  

Event Description

Life links pads applied prior to surgery (tavr).During procedure, pt went into v fib and received numerous defibrillations.When pads removed, burns noted to left lateral chest and right upper back.

• Brand Name: LIFELINKS
• Type of Device: DEFIBRILLATION / CARDIOVERSION PADS
• Manufacturer (Section D): TZ MEDICAL; portland OR
• MDR Report Key: 4387161
• MDR Text Key: 15972910
• Report Number: MW5039953
• Device Sequence Number: 1
• Product Code: LDD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P-211-M1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 73