MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL DEFIBRILLATOR MACHINE; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number 8011014003

Device Problem Failure to Deliver Shock/Stimulation (1133)

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

Event Date 05/20/2020

Event Type  Injury  

Event Description

Trauma pt, pt has stab wound; surgery: opened chest, pulled core crash cart brought to operating room, opened # 1 sterile zoll internal defibrillator paddles, but it malfunctioned.Run to pacu and pulled pacu crash cart and connected paddles to pacu zoll defibrillator machine.Again, did not work.Meanwhile, ir crash cart was also pulled to operating room, opened a new second set of defibrillator paddles from ir crash cart that was functioning.Sent # 1 malfunction internal defibrillator paddles to spd to recheck.Fda safety report id # (b)(4).

• Brand Name: ZOLL DEFIBRILLATOR MACHINE
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 10091674
• MDR Text Key: 192635194
• Report Number: MW5094684
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/22/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8011014003
• Device Lot Number: 0382-3205-360125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR