MAUDE Adverse Event Report: GE HEALTHCARE INNOVA 2100-IQ; SYSTEM, X-RAY, ANGIOGRAPHIC

Device Problem Output above Specifications (1432)

Patient Problem No Information (3190)

Event Date 05/26/2017

Event Type  malfunction  

Event Description

During preventative maintenance of fluoroscopy, the field service engineer noted on his meter that there were periods of increased radiation happening when the fluoro pedal was not in use.The room was closed for use.Replacement part was ordered and replaced and the room was reopened for use after it met all service checks.Manufacturer response for fluoroscopy, (brand not provided) (per site reporter).A new part was needed, ordered and replaced.

• Brand Name: INNOVA 2100-IQ
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): GE HEALTHCARE; 3000 n grandview blvd.; waukesha WI 53188
• MDR Report Key: 6958271
• MDR Text Key: 89695121
• Report Number: 6958271
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/18/2017

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: No Information
• Other Device ID Number: 531004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2017
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1