MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ONESTEP COMPLETE, SINGLE, R SERIES, ELECTRODES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 8900-0224-01

Device Problems Device Displays Incorrect Message (2591); Failure of Device to Self-Test (2937)

Patient Problem Insufficient Information (4580)

Event Date 04/18/2022

Event Type  malfunction  

Event Description

The defibrillator pad failed defib test on the transport monitor.The monitor said to check pads." the pad was not/has not been folded.

• Brand Name: ONESTEP COMPLETE, SINGLE, R SERIES, ELECTRODES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 14257439
• MDR Text Key: 290448485
• Report Number: 14257439
• 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: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8900-0224-01
• Device Catalogue Number: 8900-0224-01
• Device Lot Number: 4021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1