MAUDE Adverse Event Report: GENERAL MEDICAL MERATE S.P.A. DISCOVERY RF180; SYSTEM, X-RAY, FLUOROSCOPIC

Device Problem Use of Device Problem (1670)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 06/13/2023

Event Type  Injury  

Event Description

Ge healthcare installer received an electric shock while installing the x-ray generator (model: indico iq, cpi s/n (b)(6)) manufactured by communications & power industries (cpi).The indico iq generator is a medical device already registered in the united states (registered establishment number: 3002975048).This generator is a component of the discovery rf180 system manufactured by gmm (510(k) number: k173395).The shock occurred when the installer accidentally tripped while walking toward the x-ray generator that was on and being calibrated, and the generator covers had been removed (an unusual condition) to examine the led indicators on some of the generator subassemblies.According to the report received by gmm, the installer tripped over his feet and fell.His right forearm came into contact with exposed live circuits, and the employee suffered an electric shock and third-degree burns to his forearm.

• Brand Name: DISCOVERY RF180
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC
• Manufacturer (Section D): GENERAL MEDICAL MERATE S.P.A.; via partigiani, 25; seriate, bergamo 24068 ; IT 24068
• Manufacturer (Section G): GENERAL MEDICAL MERATE S.P.A.; via partigiani, 25; seriate, bergamo 24068 ; IT 24068
• Manufacturer Contact: luca bianchessi ; via partigiani, 25; seriate, bergamo 24068 ; IT 24068
• MDR Report Key: 17445611
• MDR Text Key: 320253848
• Report Number: 3002807092-2023-00001
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/31/2023

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
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White