MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ONESTEP ADULT ELECTRODES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 8900-0224-01

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 06/29/2023

Event Type  malfunction  

Event Description

Patient coded and defibrillator was used.When shocking patient, sparks came from the pacer pads.Pacer pads replaced and shocked patient again.Pads sparked again.Third set of pacer pads did not throw sparks.Work order was placed on defibrillator.Defibrillator was replaced on unit.Unable to know the lot # of pads that were used.Items not saved during code and when room was searched, environmental services (es) had already cleaned the room.I attempted to look through the trash, but it was already sent down the trash chute.The crash carts and defibrillators are checked daily per policy.The defibrillator was checked two days prior.The "adult one-step" electrodes had an expiration date of 04/2025.The defibrillator was tested and steps 1-8 were completed and documented.Registered nurse (rn) was doing compressions.When the patient was defibrillated, she said it was "sparking underneath where it was on the edge and sizzled his chest hair".Nurse tech stated she was in the room, did not see sparks but stated like it smelled like there was an electrical fire and burned hair.

• Brand Name: ONESTEP ADULT ELECTRODES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 17479715
• MDR Text Key: 320587696
• Report Number: 17479715
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/03/2023,06/30/2023

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 Model Number: 8900-0224-01
• Device Catalogue Number: 8900-0224-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Sex: Male