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

Model Number	8900-000280-01
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
Event or Problem Description
Complaint alleged that during a routine shift check by a clinician, the associated device inappropriately displayed a "plug in cable" message using these electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The actual cpr uni-padz iii from the event were not available for evaluation.  instead, electrodes from retained samples of the same lot number 3521c were investigated.  evaluation of the retained electrodes did not reveal any irregularities that would have contributed to the reported event and concluded that the samples were assembled according to specification.No trend is associated with reports of this type.
Additional Manufacturer Narrative
The electrodes were returned to zoll medical corporation for evaluation.The customer's report was not replicated or confirmed.The electrodes were put through extensive testing without duplicating the report.A visual inspection of the electrode cable and connector found no discrepancies.The electrodes were scrapped after investigation.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: CPR UNI-PADZ, III, U.S.
• 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: 16932533
• Report Number: 1218058-2023-00098
• Device Sequence Number: 17985791
• Product Code: MKJ
• UDI-Device Identifier: 00847946027179
• UDI-Public: 00847946027179
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2023

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: 08/27/2023
• Device Model Number: 8900-000280-01
• Device Catalogue Number: 8900-000280-01
• Device Lot Number: 3521C
• 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: 04/24/2023
• Supplement Date Received by Manufacturer: 04/24/2023; 04/24/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 06/15/2023; 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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