MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONE STEP PEDIATRIC CPR ELECTRODE

Model Number	8900-000219-01
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 during functional testing, the associated device was unable to capture pacing using these electrode pads.Complainant did not indicate that there was any patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Multiple sets of electrode pads were returned to evaluation.All of the electrodes were tested with a simulator and were capable of capturing during pacing, of obtaining pacer readings and discharging at all joule levels.A visual inspection of all lots did not yield any discrepancies and all lots were found to have been assembled correctly.There was no evidence found that suggests the electrodes contributed to the lack of capture/ecg signal during pacing.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ONE STEP PEDIATRIC CPR ELECTRODE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 9545803
• Report Number: 1218058-2019-00185
• Device Sequence Number: 14028456
• Product Code: MKJ
• UDI-Device Identifier: 00847946023348
• UDI-Public: 00847946023348
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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 Model Number: 8900-000219-01
• Device Catalogue Number: 8900-000219-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1