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

Model Number	8900-0215-40
Medical Device Problem Code	Failure of Device to Self-Test (2937)
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 device failed self test with the attached electrodes.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive testing which included multiple 30 joule testing and visual inspection without duplicating the malfunction.The electrodes were scrapped onsite.No trend is associated with reports of this type.
Additional Manufacturer Narrative
The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.

• 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: 8641773
• Report Number: 1218058-2019-00049
• Device Sequence Number: 2662793
• Product Code: MKJ
• UDI-Device Identifier: 10847946016231
• UDI-Public: 10847946016231
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 05/03/2019

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: 03/26/2020
• Device Model Number: 8900-0215-40
• Device Catalogue Number: 8900-0215-40
• Device Lot Number: 1318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 05/03/2019; 05/03/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 06/07/2019; 06/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1