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

Model Number	8900-000420-01
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	10/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Three patients developed significant large skin tears with removal of zoll pads requiring wocn (wound, ostomy, and continence nurses) consult and wound treatment.

• Brand Name: ONESTEP
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 21240116
• Report Number: 21240116
• Device Sequence Number: 3627837
• Product Code: MKJ
• UDI-Device Identifier: 00847946021221
• UDI-Public: (01)00847946021221
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/23/2025
• Report Date (Section F): 01/23/2025

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
• Operator of Device: Health Professional
• Device Model Number: 8900-000420-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/23/2025