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

Model Number P-211-Z1

Device Problems Smoking (1585); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2015

Event Type  malfunction  

Event Description

During defibrillation of patient, staff states there was a "pop" noise and smoke from the defibrillator pads.Patient was successfully defibrillated at 200j using the tz medical defib pads (p-211-z1) attached to the high output defibrillator in the operating room.Soot was seen at the left lateral side of the patient and defibrillator pad.Pads were immediately removed from patient and replaced with a new set.No burns were apparent on patient skin noted, device and pads taken out of service for further evaluation manufacturer response for tz transparent defibrillator pads (tz medical defib pads (p-211-z1), defib pads (per site reporter).Unknown at this time.

Event Description

During defibrillation of patient, staff states there was a "pop" noise and smoke from the defibrillator pads.Patient was successfully defibrillated at 200j using the tz medical defib pads (p-211-z1) attached to the high output defibrillator in the operating room.Soot was seen at the left lateral side of the patient and defibrillator pad.Pads were immediately removed from patient and replaced with a new set.No burns were apparent on patient skin noted, device and pads taken out of service for further evaluation manufacturer response for tz transparent defibrillator pads (tz medical defib pads (p-211-z1), defib pads (per site reporter).Unknown at this time.

• Brand Name: LIFELINKS (ADULT)
• 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: 6989939
• MDR Text Key: 90689989
• Report Number: 6989939
• Device Sequence Number: 1
• Product Code: DRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: P-211-Z1
• Device Catalogue Number: P-211-Z1
• Other Device ID Number: TZ TRANSPARENT DEFIBRILLATOR
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/23/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1