MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO-PADZ LIQUID GEL RADIOLUCENT MFE, 1 SET; ELECTRODE

Model Number	8900-2106-01
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to treat a 61-year-old female patient, the associated device failed to discharge using these electrode pads.Clinicians indicated they repositioned the same pads and delivered the shock without synchronization in manual mode.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the returned electrode pads and the customer's report was not replicated or confirmed.The electrode pads were tested on an analyzer and functionally delivered energy successfully.Visual inspection of the pads observed some discoloration on the foam of both pads but did not observe any irregularities consistent with the customer report.No trend is associated with reports of this type.

• Brand Name: PRO-PADZ LIQUID GEL RADIOLUCENT MFE, 1 SET
• 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: 15710694
• Report Number: 1218058-2022-00119
• Device Sequence Number: 14685606
• Product Code: MKJ
• UDI-Device Identifier: 00847946016401
• UDI-Public: 00847946016401
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 10/17/2022

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: 06/04/2023
• Device Model Number: 8900-2106-01
• Device Catalogue Number: 8900-2106-01
• Device Lot Number: 2322B
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 10/17/2022; 10/17/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 01/15/2023; 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2022
• 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 Age: 61 YR
• Patient Sex: Female
• Patient Weight: 58 KG