MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONESTEP PEDIATRIC RESUSCITATION ELECTRODE; ELECTRODES

Model Number	8900-0218-40
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the associated defibrillator recognized these adult electrode pads as pediatric electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
This follow up medwatch report is reporting the evaluation of the device.This follow up medwatch report is also correcting information submitted on the initial medwatch report.The device was returned to zoll medical corporation; the malfunction was duplicated and attributed to a faulty connector on the electrode.Due to the fact that this occurrence does not prevent the associated defibrillator from delivering therapy, this medwatch report was submitted in error.Analysis for reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the associated defibrillator failed readiness test using these electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.

• Brand Name: ONESTEP PEDIATRIC RESUSCITATION ELECTRODE
• Common Device Name: ELECTRODES
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 7150864
• Report Number: 1218058-2017-00143
• Device Sequence Number: 1066001
• Product Code: MKJ
• UDI-Device Identifier: 00847946016234
• UDI-Public: 00847946016234
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2017

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: 08/13/2019
• Device Model Number: 8900-0218-40
• Device Catalogue Number: 8900-0218-40
• Device Lot Number: 3315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1