MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONESTEP RESUSCITATION ELECTRODE (8 PER CASE)

Model Number	8900-0211-01
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
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 cardiovert a patient (age & gender unknown), the associated defibrillator was unable to detect the attached electrode pads.Complainant indicated that the clinician obtained another device 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 electrode pads were not returned to zoll medical corporation for evaluation.Instead, a lot number of the pads was provided.An investigation was conducted on retained samples of onestep resuscitation electrode, lot 3522 for the customer's report.Evaluation of the electrodes did not reveal any irregularities that would have contributed to the reported event.Based on the evaluation of the retained samples it was concluded that the samples were assembled according to specification without duplicating the report.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ONESTEP RESUSCITATION ELECTRODE (8 PER CASE)
• 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: 15932676
• Report Number: 1218058-2022-00133
• Device Sequence Number: 4459895
• Product Code: MKJ
• UDI-Device Identifier: 10847946016248
• UDI-Public: 10847946016248
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 11/16/2022

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: 08/27/2024
• Device Model Number: 8900-0211-01
• Device Catalogue Number: 8900-0211-01
• Device Lot Number: 3522
• 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: 11/16/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2022
• 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 Sex: Unknown