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 a routine shift check by a clinician, the associated defibrillator displayed a "poor pad contact" message with these electrodes.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The electrode pads were returned to zoll medical corporation.Testing of the electrode pads was unable to duplicate the customer's report.The electrodes passed all testing and no discrepancies were found during the visual inspection.The electrode pads were scrapped.A retained sample investigation for the lot number 2417 was conducted and concluded that the retained pair of electrodes were assembled according to specification.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: 8651614
• Report Number: 1218058-2019-00062
• Device Sequence Number: 2117870
• Product Code: MKJ
• UDI-Device Identifier: 00847946023348
• UDI-Public: 00847946023348
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 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: 06/11/2019
• Device Model Number: 8900-000219-01
• Device Catalogue Number: 8900-000219-01
• Device Lot Number: 2417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• 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: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1