MAUDE Adverse Event Report: BIO-DETEK INCORPORATED CPR STAT PADZ HVP MULTI-FUNCTION CPR ELECTRODES -

Model Number	8900-0402
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/08/2020
Type of Reportable Event	Death
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 while attempting to defibrillate a (b)(6)-year-old female patient, the associated defibrillator was unable to obtain an ecg signal with these electrode pads attached.Complainant indicated that the clinician obtained another set of electrode pads to continue treating the patient and an ecg signal was obtained.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
The electrode pads have not been returned to zoll for evaluation.The electrode lot number is unknown, therefore no retained sample testing could be performed.No clinical data or device activity logs from the event was provided.This claim has been closed as no sample returned.

• Brand Name: CPR STAT PADZ HVP MULTI-FUNCTION CPR ELECTRODES -
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 9649889
• Report Number: 1218058-2020-00001
• Device Sequence Number: 2784544
• Product Code: MKJ
• UDI-Device Identifier: 00847946016319
• UDI-Public: 00847946016319
• 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): 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 8900-0402
• Device Catalogue Number: 8900-0402
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death