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

Lot Number R2018-33

Patient Problems Cardiac Arrest (1762); Heart Block (4444); Respiratory Arrest (4461)

Event Date 07/01/2023

Event Type  malfunction  

Event Description

Zoll onestep cpr pads did not function as intended: the pads were applied immediately in the code (by an intensive care unit registered nurse), and they attempted to pace the patient who developed complete heart block, only to have lack of capture with the first set of pads.A second set was placed (after compressions and the like) with capture and successful transcutaneous (tc) pacing.Device given to zoll representative.

• Brand Name: ONESTEP R SERIES CPR PADS
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 17689497
• MDR Text Key: 322716227
• Report Number: 17689497
• 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: 07/11/2023

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: R2018-33
• 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: 07/11/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1