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

Model Number	8900-0400
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	Insufficient Information (4580)
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), the pads were damaged during opening/removal of packaging, causing a delay in therapy.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section d4 (lot# and expiration date) and h4.Evaluation: the electrode pads were returned to zoll medical corporation; the customer's report was observed on the sample electrodes returned from the customer.Some signs of gel lifting were observed after removing the pad from the styrene liner, but mostly intact.In most of the returned samples returned by the customer, the gel remained intact with the electrode where it would not impact application of the electrode pads to the patient.Evaluation of the retained electrodes did not reveal any irregularities that would have contributed to the reported event.The customer's returned pads were scrapped after evaluation.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: CPR STAT PADZ
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 14917552
• Report Number: 1218058-2022-00075
• Device Sequence Number: 5813625
• Product Code: MKJ
• UDI-Device Identifier: 10847946016316
• UDI-Public: 10847946016316
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

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: 12/09/2023
• Device Model Number: 8900-0400
• Device Catalogue Number: 8900-0400
• Device Lot Number: 5021C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/20/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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