MAUDE Adverse Event Report: BIO-DETEK INCORPORATED CPR STAT-PADZ; ELECTRODES

Model Number	8900-0402
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), they had extreme difficulty removing the backing from pads during opening the packaging, they were unable to remove the backing.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The cpr stat-padz were returned to zoll medical canada for evaluation.The cpr stat-padz were observed to have physical damage caused by the user opening the pads incorrectly.The instruction for use for cpr stat-padz state: "grasp the apex/lateral electrode at the tab and peel away the plastic liner." if the user has the pads pre-connected, the instruction for use for cpr stat-padz state for pre-connecting the electrodes: "do not open until ready for use, periodically inspect the electrode packaging for integrity and expiration date, attach electrodes connector to zoll multi-function cable connector, and open electrode package by pulling apart at red arrow".The user was sent replacement pads.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: CPR STAT-PADZ
• Common Device Name: ELECTRODES
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: tina lombari ; 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 21091167
• Report Number: 1218058-2024-00116
• Device Sequence Number: 18299953
• Product Code: MKJ
• UDI-Device Identifier: 00847946016319
• UDI-Public: (01)00847946016319(17)260319(10)1224F
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P160022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2024

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: Other
• Device Expiration Date: 03/19/2026
• Device Model Number: 8900-0402
• Device Lot Number: 1224F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown