MAUDE Adverse Event Report: BIO-DETEK INCORPORATED CPR UNI-PADZ, III; ELECTRODES

Model Number	8900-000280
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's report was duplicated and attributed to faulty cpr uni padz.The cpr uni padz was scrapped and a replacement was sent to the customer.Analysis of reports of this type has not identified an increase in trend.
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 during incoming inspection, the associated defibrillator was unable to detect the attached electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.

• Brand Name: CPR UNI-PADZ, III
• 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: 19247831
• Report Number: 1218058-2024-00045
• Device Sequence Number: 6598657
• Product Code: MKJ
• UDI-Device Identifier: 00847946026691
• UDI-Public: 00847946026691
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/15/2024

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 Model Number: 8900-000280
• Device Catalogue Number: 8900-000280
• Device Lot Number: 4923A
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2023
• 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