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

Lot Number 2722K

Device Problem Communication or Transmission Problem (2896)

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 05/27/2023

Event Type  malfunction  

Event Description

The pads were applied without difficulty and appeared intact when applied.2 rounds of cpr were completed with pads.The pads were picking up appropriate rhythm.After sync cardioversion, zoll stated that connection was lost with the pads although they were still picking up an appropriate rhythm.Pads removed and new set applied.

• Brand Name: ONESTEP
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 17085875
• MDR Text Key: 316771871
• Report Number: 17085875
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2023

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 Operator: Health Professional
• Device Lot Number: 2722K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1