MAUDE Adverse Event Report: FIAB SPA EURODEFIPADS; DISPOSABLE MULTIFUNCTION ELECTRODES

Model Number F7750

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Insufficient Information (4580)

Event Date 03/16/2023

Event Type  malfunction  

Event Description

Here follows what is stated in the incident report form: "even though the plate was applied correctly, it did not conduct the electrical impulse.Attempted four unsuccessful discharges.It was necessary to proceed with the use of sets for internal cardiac defibrillation".No specific information reported on consequences and health status for the patient.Generally reported "unexpected deterioration".

Manufacturer Narrative

Notes from manufacturer to fda: 1.The event occurred in italy (not in us).2.The product reported involved in the incident - model f7750 - is identical to the product cleared for the marketing in us under the 510(k) k103783 and having model nr.U7750.Evaluation: the device involved was discarded, therefore it is not possible to carry out an assessment of the event based on a technical investigation of the device.Since the device involved is not available, fiab immediately contacted the healthcare facility to organize a site ispection in order to verify the event reported and carry out the appropriate technical verification on samples of electrode belong to the same lot involved in the event (23df0427) and available at the facility and on the defibrillator itself.The site inspection by fiab technicians at the healthcare facility took place on 31 march 2023 and the following technical verification and assessments were carried out as described below.Using the analyzer simulator (defibrillator/pacer analyzers - mod.Phase 3) supplied by the clinical engineering service of the healthcare facility , a test was carried out on a pair of disposable electrodes belong to the same lot involved in the event (23df0427) that was connected to a philips defibrillator model heartstart xl.During the test the correct diagnostic capacity was verified ( clean and readable qrs complex) and an absolute effectiveness of the discharge (test carried out with settings up to 20 joules for the quantity of energy supplied).During the sit inspection it was reported that before the inspection by fiab, a technician from the medical physics operative unit - asst spedali civili of brescia, had carried out the same checks, confirming the effectiveness and efficiency of the eurodefipads disposable electrodes for defibrillation - fiab mod.F7750 (lot number 23df0427).Based on the information provided on the test carried out by the technician of the healthcare facility and on the basis of the technical checks carried out during the site inspection by the fiab technicians, it is assumed that the reported malfunction may be due to an accidental disconnection between the connection cable and the philips defibrillator mod.Heartstart xl that caused unsuccessful discharges of the fiab electrodes during the procedure.According to the verification performed, no corrective/preventive action has been implemented.

• Brand Name: EURODEFIPADS
• Type of Device: DISPOSABLE MULTIFUNCTION ELECTRODES
• Manufacturer (Section D): FIAB SPA; via costoli n 4; vicchio, florence 50039 ; IT 50039
• Manufacturer (Section G): FIAB SPA; via costoli n 4; vicchio, florence 50039 ; IT 50039
• Manufacturer Contact: francesco bastistini ; via costoli n 4; vicchio, florence 50039 ; IT 50039
• MDR Report Key: 16773011
• MDR Text Key: 313640856
• Report Number: 3003072803-2023-00001
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 08033003268469
• UDI-Public: 8033003268469
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/19/2023

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
• Device Operator: Health Professional
• Device Model Number: F7750
• Device Catalogue Number: F7750
• Device Lot Number: 23DF0427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2023
• Initial Date FDA Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR