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

Model Number	8900-0213-01
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 during a routine shift check by a clinician, the associated device failed to discharge with the attached electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.The customer was contacted for return of the suspect product.The customer has responded and indicated the product will not be returning to zoll.

• Brand Name: ONESTEP CPR (AP) ELECTRODE, 8 PER CASE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 8650488
• Report Number: 1218058-2019-00059
• Device Sequence Number: 19365472
• Product Code: MKJ
• UDI-Device Identifier: 10847946016262
• UDI-Public: 10847946016262
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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: 09/17/2020
• Device Model Number: 8900-0213-01
• Device Catalogue Number: 8900-0213-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1