MAUDE Adverse Event Report: EL.EN. ELECTRONIC ENGINEERING S.P.A. ELITE IQ

Model Number	M122B1
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On may the 8th, 2024, el.En.Electronic engineering spa received a communication from the us importer (b)(6) of an of an event in which the device elite iq double pulsed just before showing a low-power alarm.In the above-mentioned communication is reported the following: the customer complaint of two faults occurring relative to low-energy alarm and starting to double-pulse.Anyway, the customer reported to have been able to bypass this issue simply by re-starting the device.In the communication it is reported that no patient nor operator has been involved in the event.The present event has been evaluated as a reportable due to the fact that the event represent an accidental radiation occurrence (aro).Moreover, the us importer, (b)(6), proceeded to submit their own mdr report code mdr 1222993-2024-00019 in date april the 26th, 2024.We the manufacturer of the device proceeded to submit our own mdr report, in accordance with 21 cfr part 803.50(2) in order to supply any missing information.
Additional Manufacturer Narrative
We as manufacturer of the device have performed our own investigation based on the information gathered by the us importer from the clinic.In date 24/04/2024 the actual device involved in the event has been evaluated by (b)(6)authorized technician who was unable to replicate the error reported by the site.The device has been checked thoroughly and no issue has been found device working properly within specification.Moreover the technician remain at the site and observed the nurse performing treatment on 5 patient during which the device worked properly without any issue and without presenting any kind of alarm.Based on the fact that the issue was impossible to replicate and that the device has been found working properly within specifications the root cause of the event has not been possible to be determined.It has not been possible, also to confirm the happening of the event.No design deficiency has been found to be contributory to the event.No corrective action/preventive action/fsca is required.The present initial report has to be considered as a final report unless fda has further questions.

• Brand Name: ELITE IQ
• Common Device Name: ELITE IQ
• Manufacturer (Section D): EL.EN. ELECTRONIC ENGINEERING S.P.A.; via baldanzese 17; calenzano, 50041 ; IT 50041
• Manufacturer (Section G): EL.EN. ELECTRONIC ENGINEERING S.P.A.; via baldanzese, 17; calenzano, 50041 ; IT 50041
• Manufacturer Contact: andrea checchi ; via baldanzese, 17; calenzano, firenze 50041 ; IT 50041
• MDR Report Key: 19447396
• Report Number: 3001431138-2024-00009
• Device Sequence Number: 15580436
• Product Code: GEX
• UDI-Device Identifier: 08057017760450
• UDI-Public: (01)08057017760450(11)230309
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K193426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: 505
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2024

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: Health Professional
• Device Model Number: M122B1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown