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

Model Number	8900-2106-01
Medical Device Problem Codes	Compatibility Problem (2960); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device 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 device's defib output was out of specification.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The device was not returned for evaluation.The data file and visual data from the event was returned and evaluated.A review of the provided data file and visual data showed an impedance load of 175 and a discharge of approximately 290j, which falls within the device specification based on the selected energy + load (patient's impedance) and -/+ 15% accuracy of the target delivery of 260j.After review of the data file and pictures, it was concluded that the resulted outcome is within the expected performance of the device and electrodes.Analysis of reports of this type has not identified an increase in trend.

• 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
• MDR Report Key: 11102270
• Report Number: 1218058-2020-00102
• Device Sequence Number: 19645242
• Product Code: MKJ
• UDI-Device Identifier: 00847946016401
• UDI-Public: 00847946016401
• 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): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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: 10/22/2020
• Device Model Number: 8900-2106-01
• Device Catalogue Number: 8900-2106-01
• Device Lot Number: 4319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1