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

Model Number 8900-0224-01

Patient Problem Asystole (4442)

Event Date 09/19/2023

Event Type  Death  

Event Description

Patient found down by bystander physical therapist assistant (pta), unknown amount of time.Ems rhythm asystole, advanced life support (acls) initiated in field.Patient arrived in pulseless electrical activity (pea) from leads pacer pads applied, did not register, second set applied first removed, still did not register, patient pronounced shortly after second application of pads.Expiration for lot# 2923k 7/22/25.

• Brand Name: ONESTEP
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 525 narragansett park dr; pawtucket RI 02861
• MDR Report Key: 18237501
• MDR Text Key: 329372147
• Report Number: 18237501
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8900-0224-01
• Device Catalogue Number: 8900-0224-01
• Device Lot Number: 0622J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2023
• Date Report to Manufacturer: 11/30/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death