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 Defective Component (2292); Failure of Device to Self-Test (2937)

Patient Problem Insufficient Information (4580)

Event Date 04/17/2023

Event Type  malfunction  

Event Description

Clinical engineering was investigating a zoll in icu from a trouble call.The zoll machine was failing its status check.Clinical engineering tested zoll machine and found no issue.When zoll was connected to pads, zoll machine failed its status check.Clinical engineering tested a different set of pads on zoll machine and the zoll passed the status check.Clinical engineering suspected zoll pads were defective so he tested questionable zoll pad on another zoll and the zoll failed its status check.It was determined that zoll was working fine, pads were not working correctly.The zoll charge would not release with the defective pads.

• 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: 16843323
• MDR Text Key: 314285076
• Report Number: 16843323
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016272
• UDI-Public: (01)00847946016272(17)241119(10)47228
• 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: 04/26/2023

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: 8900-0224-01
• Device Catalogue Number: 8900-0224-01
• Device Lot Number: 47228
• 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: 04/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1