MAUDE Adverse Event Report: FIAB SPA DEFICOM; F7952 DISPOSABLE MULTIFUNCTION ELECTRODES WITH CONNECTOR FOR DEFIBRILLATORS

Model Number F7952

Device Problem Component Misassembled (4004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

The event occurred in eu (france) not in us.The product reported in the incident, model f7952, is identical to the product cleared for the marketing in us and under the 510(k) k103783.The distributor comepa industries reported to the manufacturer fiab spa what had been reported by a customer (final user) of the product: the connector of the electrodes doesn't match neither the diagram on the bag nor the connector on the defibrillator.This "product malfunction" is related only to a specific batch )(ot number 23df1479) of the personalized model manufactured for the distgributor comepa under the brand deficom, marketed only in france and the corrective actions defined and in progress of implementaion (fsca) involve this batch only.The assessment of the problem has already been carried out by fiab spa as manufacturer and this "malfunction product" is due to an error during the assembly stage of a component due to an accidental and isolated error by a production operator.

Event Description

The french distributor comepa industries reported to the manufacturer fiab spa what had been reported by a customer (final user) of the product: the connector of the electrodes doesn't match neither the diagram on the bag nor the connector on the defibrillator.Opening a second bag from the same batch, the connector matched perfectly.The event reported by the distributor, although it did not cause any harm to a patient, could have caused a delay in using the device due to the impossibility of connecting the defibrillation electrodes to the expected defibrillator (due to the incorrect connector found inside the pouch).The manufacturer's assessment is therefore that this event represents an unacceptable risk and to be reported as a serious incident under eu vigilance requirements.Although it can be preliminarily assessed that this is an isolated case due to an accidental error in the packaging phase of the specific production batch, in light of the unacceptable risk assessment it was decided to proceed with the issuance of an fsn to remove the product of this batch from the market via an fsca.According to the analysis and checks perfomed, the fsca involves only lot number 23df1479 distributed only in france by the distributor comepa industries.

• Brand Name: DEFICOM
• Type of Device: F7952 DISPOSABLE MULTIFUNCTION ELECTRODES WITH CONNECTOR FOR DEFIBRILLATORS
• Manufacturer (Section D): FIAB SPA; via costoli 4; vicchio, florence 50039 ; IT 50039
• Manufacturer (Section G): FIAB SPA; via costoli 4; vicchio, florence 50039 ; IT 50039
• Manufacturer Contact: francesco batistini ; via costoli 4; vicchio, florence 50039 ; IT 50039
• MDR Report Key: 18375019
• MDR Text Key: 331368434
• Report Number: 3003072803-2023-00004
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K103783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: F7952
• Device Catalogue Number: F7952
• Device Lot Number: 23DF1479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2023
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2023
• 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