MAUDE Adverse Event Report: BIO-DETEK INCORPORATED STAT PADZ HVP MULTI FUNCTION ELECTRODES; DEFIB/PACING ELECTRODE

Model Number	8900-4004
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/23/2018
Type of Reportable Event	Death
Event or Problem Description
Complainant alleged that while attempting to defibrillate a female patient (age unknown) the electrode packaging was opened and it was discovered that there were no electrodes inside.Complainant indicated that the clinician obtained another set of electrodes to continue treating the patient.Complainant indicated that due to the delay in therapy, the patient subsequently expired.
Additional Manufacturer Narrative
The electrode packaging was received at zoll medical corporation for evaluation.Visual inspection of the electrode packaging provides evidence that the electrodes were in the packaging during the time of manufacture.The electrode packaging shows a void in the adhesive heat seal line where the grommet is secured around the cable at the proper location.The grommet is attached as part cable assembly and cannot be sealed within the packaging without being installed onto the cable based on the fixture used to aid in the sealing process.Our evaluation has concluded that the electrodes were inside of the packaging prior to distribution of the product.Therefore this claim is being closed as evidence supports report was unsubstantiated.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: STAT PADZ HVP MULTI FUNCTION ELECTRODES
• Common Device Name: DEFIB/PACING ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 7228292
• Report Number: 1218058-2018-00008
• Device Sequence Number: 19088441
• Product Code: MKJ
• UDI-Device Identifier: 00847946016456
• UDI-Public: 00847946016456
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

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 Expiration Date: 10/29/2019
• Device Model Number: 8900-4004
• Device Catalogue Number: 8900-4004
• Device Lot Number: 4417D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2001
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 04/09/2018
• 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