MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, ONESTEP CPR

Model Number	8900-0223-01
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2019
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 while attempting to treat a (b)(6) year-old-male patient during cardioversion, the device recognized the attached adult electrodes as pediatric electrodes.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The electrode pads involved were returned for evaluation.The customer's report was not replicated or confirmed.The electrode pads tested and were recognized as adult pads only throughout all testing.The chip reader was used and confirmed that the pads were adult and manufactured on 12/18/18 lot 5118.The pads were able to shock into a simulator at 200 joules with no discrepancies found.The electrode pads were scrapped.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, ONESTEP CPR
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 8894287
• Report Number: 1218058-2019-00110
• Device Sequence Number: 289743
• Product Code: MKJ
• UDI-Device Identifier: 00847946016265
• UDI-Public: 00847946016265
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/24/2019

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: 12/17/2020
• Device Model Number: 8900-0223-01
• Device Catalogue Number: 8900-0223-01
• Device Lot Number: 5118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR