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

Model Number R2048-01

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

Event Date 09/07/2023

Event Type  malfunction  

Event Description

Patient required cardiopulmonary resuscitation (cpr) for pulseless electrical activity (pea) arrest.Gel of the front & back pads of the onestep rolled significantly.Pads were retained and zoll will be contacted to return pads.

• Brand Name: ONESTEP CPR PADS
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 525 narragansett park dr; pawtucket RI 02861
• MDR Report Key: 18551873
• MDR Text Key: 333352345
• Report Number: 18551873
• 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: 09/08/2023

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 Model Number: R2048-01
• Device Catalogue Number: R2048-01
• Device Lot Number: 1023H
• 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: 09/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1