MAUDE Adverse Event Report: TZ MEDICAL, INC. DEFIBRILLATION ELECTRODES; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number P-211-Z1

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

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 12/11/2021

Event Type  malfunction  

Event Description

Patient was cardioverted three times in the emergency room.After procedure was done and pads were removed.Burns were present on the chest.

• Brand Name: DEFIBRILLATION ELECTRODES
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): TZ MEDICAL, INC.; 17750 sw upper boones ferry rd ste 150; portland OR 97224
• MDR Report Key: 13051706
• MDR Text Key: 282570258
• Report Number: 13051706
• Device Sequence Number: 1
• Product Code: DRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P-211-Z1
• Device Lot Number: Y100821-11
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28470 DA
• Patient Sex: Female