MAUDE Adverse Event Report: BIO-DETEK INCORPORATED STAT-PADZ; DEFIB/PACING ELECTRODE

Model Number	8900-4004
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
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 associated defibrillator displayed a "poor pad contact" message using these electrode pads.Complainant indicated that the clinician obtained a second set of pads from the same lot number and continued to get the poorr pad contact message.The clinician then used pads from a different lot number to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The actual stat-padz from the event were not available for evaluation.Instead, electrodes from retained samples of the same lot number 1424a were investigated.The retained samples were subjected to a continuity test, discharge testing, and impedance testing with passing results.A visual inspection found the lot assembly built according to specification.Review of all records were performed and passed.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 associated with similar reports.

• Brand Name: STAT-PADZ
• Common Device Name: DEFIB/PACING ELECTRODE
• 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: 20030067
• Report Number: 1218058-2024-00080
• Device Sequence Number: 18311348
• Product Code: MKJ
• UDI-Device Identifier: 00847946016456
• UDI-Public: (01)00847946016456(17)260402(10)1424A
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P160015
• 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
• Report Date (Section B): 07/31/2024

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: 04/02/2026
• Device Model Number: 8900-4004
• Device Lot Number: 1424A
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2024
• 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