MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ONESTEP CPR AA; AID, CARDIOPULMONARY RESUSCITATION

Model Number	8900-0225-01
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Checked zoll defibrillator for routine check and defibrillator reading "check pads".Connected another set of defibrillator pads and was able to complete zoll check.Removed pads from inventory.

• Brand Name: ONESTEP CPR AA
• Common Device Name: AID, CARDIOPULMONARY RESUSCITATION
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 19536385
• Report Number: 19536385
• Device Sequence Number: 12368499
• Product Code: LIX
• UDI-Device Identifier: 00847946016289
• UDI-Public: (01)00847946016289
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 03/14/2024
• Report Date (Section F): 03/14/2024

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: 8900-0225-01
• Device Lot Number: 0524A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/14/2024