MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION DEFIBRILLATOR PADS - ONESTEP CPR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 8900-0223-01

Device Problem Fire (1245)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 11/15/2022

Event Type  Injury  

Event Description

Code blue called on patient on (b)(6) 2022.Fire with defibrillator pads during first defib.Pads were removed.New pads placed on patient.No burns to patient.Defib x4 with rosc (return of spontaneous circulation).Ekg with st elevations.

• Brand Name: DEFIBRILLATOR PADS - ONESTEP CPR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824 4105
• MDR Report Key: 16461741
• MDR Text Key: 310452315
• Report Number: MW5115330
• Device Sequence Number: 1
• Product Code: MKJ
• 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: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8900-0223-01
• Device Lot Number: 2922
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White